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compositionComposition:CYPROTERONE-2MG+ETHINYLESTRADIOL-0.035MG
prescription
Prescription Medicine
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Diane 35 Tablet contains Ethylestradiol and Cyproterone. It is used to treat moderate to severe acne related to androgen sensitivity and/or hirsutism (excess hair growth) in women of reproductive age. It works by blocking the production of androgens (male hormones) in the ovaries, thereby helping reduce acne and hair growth. In some cases, this medication may cause nausea, abdominal pain, headache, weight gain and mood changes. Before starting this medicine, inform your doctor if you are pregnant, breastfeeding, taking any other medicines or have pre-existing medical conditions.

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Written By Ms. Santoshini Reddy , M Pharmacy
Reviewed By Dr. Lalit Kanodia , MBBS, MD, MBA Healthcare Adminiatration
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More about the Product

Composition :

CYPROTERONE-2MG+ETHINYLESTRADIOL-0.035MG

Manufacturer/Marketer :

Bayer Zydus Pharma Pvt Ltd

Consume Type :

Oral

Expires on or after :

Jan-27

Return Policy :

Not Returnable

About Diane 35 Tablet

Diane 35 Tablet is an oral prescription medicine used primarily to treat skin and systemic conditions linked to hormone sensitivity, such as moderate to severe acne and excessive facial or body hair growth (hirsutism) in women. It is typically prescribed when other treatments, such as topical creams or oral antibiotics, have not worked. Because of how it works in the body, it also functions as an oral contraceptive, meaning you should not take other hormonal birth control pills alongside it.

For this medicine to work effectively, you must take it consistently at the same time every day. You can take Diane 35 Tablet with or without food, though taking it with food or at bedtime may help if you experience mild nausea. Making simple lifestyle adjustments, such as maintaining a gentle skincare routine and eating a balanced diet, can support your treatment results.

Some women may experience mild side effects, including nausea, stomach ache, breast tenderness, or slight changes in body weight. While these are often temporary, you must contact your doctor immediately if you experience signs of serious conditions, such as severe leg pain, sudden chest pain, or difficulty breathing, which could indicate a blood clot.

Before taking Diane 35 Tablet , tell your doctor if you have high blood pressure, diabetes, migraines, or a family history of blood clots. Do not take this medicine if you are pregnant, breastfeeding, or have a history of liver damage, unexplained vaginal bleeding, or blood circulation disorders.

This medication can interact with certain epilepsy drugs, tuberculosis treatments, and herbal remedies, which can make it less effective. Smoking while taking Diane 35 Tablet significantly increases your risk of serious cardiovascular side effects, so avoiding tobacco is highly recommended. It is not intended for use in males, pregnant or breastfeeding individuals, or postmenopausal elderly women.

Uses of Diane 35 Tablet

Diane 35 Tablet is used to treat skin and systemic conditions due to hormone sensitivity. The detailed uses of Diane 35 Tablet are as follows:

  • Severe Acne: Diane 35 Tablet helps treat painful, deep, or inflammatory acne in women by lowering the level of male hormones (androgens) in the body, which reduces excess skin oil production.
  • Hirsutism (Excessive Hair Growth): Diane 35 Tablet helps reduce coarse, dark, and unwanted facial or body hair growth in women by blocking the action of androgens at the hair follicles.
  • Polycystic Ovary Syndrome (PCOS) Symptoms: Diane 35 Tablet helps manage symptoms of PCOS, such as irregular periods, acne, and excessive hair growth, by restoring a more balanced hormonal state.
     

Key Benefits

Diane 35 Tablet helps manage hormone-related conditions by addressing the effects of excess androgen activity in the body. By helping restore hormonal balance, it can improve skin health, reduce unwanted hair growth, and support more regular menstrual cycles. This medicine offers several key benefits:

  • Supports Clearer and Healthier Skin: By targeting hormonal factors that contribute to acne, Diane 35 Tablet helps reduce the formation of pimples, inflammatory lesions, and deep acne breakouts. This can improve skin appearance while reducing discomfort associated with acne-related inflammation.
  • Helps Reduce Unwanted Hair Growth: Diane 35 Tablet may help decrease excessive facial and body hair growth associated with hormonal imbalances. With continued treatment, hair may become finer, softer, and less noticeable, reducing the need for frequent hair removal.
  • Promotes More Regular Menstrual Cycles: For individuals experiencing irregular periods due to hormonal disturbances, Diane 35 Tablet can help establish a more predictable menstrual cycle. It may also contribute to lighter periods and reduced menstrual discomfort in some patients.
     

Directions for Use

To get the full benefit of Diane 35 Tablet and minimise side effects, follow these simple guidelines:

  • Take Diane 35 Tablet exactly as directed by your doctor.
  • Swallow the tablet whole with a glass of water. Do not chew, crush, or break the tablet.
  • Take this medicine at the same time each day to maintain a steady level of hormones in your body and ensure its effectiveness.
  • You can take Diane 35 Tablet with or without food. If you experience mild nausea, taking it after a meal or before bed can help.
  • Always follow the specific instructions on your prescription pack, and do not stop taking this medication without consulting your doctor.
     

How Diane 35 Tablet Works

Diane 35 Tablet works through the combined action of two different hormonal components that target the root causes of hormone-related skin and hair issues. The first component is an anti-androgen. It works by blocking the effects of male hormones (androgens), which women naturally produce in small amounts. When these hormones are overactive, they overstimulate the oil glands in the skin and cause abnormal hair growth. By blocking them, this component reduces oiliness and slows down excess hair growth. The second component is a synthetic oestrogen. It supports this process by increasing the levels of a specific protein in the blood that binds to excess male hormones, making them inactive. Together, these two components regulate your hormone balance to clear your skin and manage unwanted hair.
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Alcohol

Consult your doctor

It is not known whether Diane 35 Tablet interacts with alcohol. Please consult your doctor.

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Pregnancy

Unsafe

Diane 35 Tablet is not recommended during pregnancy. Please consult the doctor if you are pregnant or think you may be pregnant.

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Breast Feeding

Unsafe

Diane 35 Tablet is not recommended during lactation. Please consult the doctor if you are breastfeeding.

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Driving

Safe if prescribed

Diane 35 Tablet is unlikely to affect your ability to drive.

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Liver

Caution

Diane 35 Tablet may not be recommended for patients with severe liver disease. Please consult the doctor if you have liver problems.

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Kidney

Consult your doctor

Please consult the doctor if you have kidney problems.

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Children

Caution

Diane 35 Tablet is not recommended for children. It is only indicated after menarche.

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Heart

Caution

Please inform your doctor if you have heart problems before taking Diane 35 Tablet , as it may increase the risk of blood clots, stroke, or heart attack.

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Geriatrics

Caution

Please inform your doctor if you are geriatric before taking Diane 35 Tablet , as age increases the risk of blood clots, stroke, or heart complications. A medical evaluation can help determine safer alternatives based on your health profile.

What if I have taken an overdose of Diane 35 Tablet

Do not take more than the prescribed dose. It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding. Talk to your doctor if you have any of these symptoms.

Diet & Lifestyle Advise

  • Maintain a gentle skincare routine: Avoid harsh scrubs or squeezing acne lesions, as this can worsen inflammation. Use non-comedogenic (won't clog pores) skincare and makeup products.
  • Focus on a low-glycaemic diet: Eating whole grains, lean proteins, and plenty of vegetables can help regulate insulin levels, which is highly beneficial if you are managing PCOS-related symptoms.
  • Stay active: Regular physical activity helps improve insulin sensitivity, manage weight, and support overall hormonal balance.
  • Limit dairy and processed sugars: Some clinical evidence suggests that reducing high-glycaemic foods and excessive dairy intake can help reduce the frequency and severity of hormonal acne breakouts.
  • Protect your skin from the sun: Hormonal therapies can sometimes make your skin more sensitive to sunlight, increasing the risk of dark patches (chloasma). Apply a broad-spectrum sunscreen daily.
     

Health Queries

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How should I manage my irregular periods and weight of 82 kg, given my history of polycystic ovary syndrome (PCOS), a thyroid condition, and struggle with weight, especially after stopping my prescribed daily regimen of Diane-35, Glycephage-SR, and Thyronorm-100mg and only taking Diane-35 occasionally?

G.santoshini Reddy

G.santoshini Reddy

M Pharmacy (Pharmaceutics)

I completely understand how challenging managing PCOS, thyroid issues, and weight can be. Stopping your daily medications can significantly impact your hormones and metabolism. Thyronorm (levothyroxine) is essential for your thyroid and metabolism, while Glycephage-SR (metformin) manages insulin resistance, and Diane-35 regulates your cycle. Taking Diane-35 occasionally is not effective and can cause further irregularity. Please consult your doctor as soon as possible to safely restart your tailored treatment plan. Combined with a balanced diet and regular exercise, consistent medical management is the safest way to regulate your periods and manage your weight. You are not alone in this journey.

Since my periods are now regular without medication but my thick facial and body hair from PCOS has returned, should I see a doctor to restart medications like Diane 35, metformin, and aldactone, or is it okay to leave it untreated?

G.santoshini Reddy

G.santoshini Reddy

M Pharmacy (Pharmaceutics)

It is wonderful that your periods have become regular! However, I completely understand how frustrating the return of thick facial and body hair can be. It is highly recommended to consult your doctor before restarting medications like Diane 35, metformin, and Aldactone (spironolactone). While leaving these symptoms untreated is generally not dangerous, these medications require professional supervision to safely manage dosages and monitor side effects. Your doctor can help tailor a safe, effective treatment plan specifically for your symptoms. You do not have to manage this alone, and we can work to get this back under control.

Am I likely to experience any side effects after switching from Diane-35 to Deviry because of headaches?

G.santoshini Reddy

G.santoshini Reddy

M Pharmacy (Pharmaceutics)

It is very common to experience headaches with estrogen-containing pills like Diane-35, so switching to Deviry (medroxyprogesterone), which is a progestin-only medication, is a very reasonable step that may actually help relieve your headaches. As your body adjusts to this hormonal change, you might experience some mild, temporary side effects such as irregular spotting, breast tenderness, or slight mood fluctuations. These symptoms are generally mild and usually settle within a few weeks as your body stabilizes. I am here to support you, so please keep your doctor updated on how you feel during this transition.

I have been taking Diane 35 for 21 days, followed by a 7-day break, along with vitamin tablets and Normoz DS. My periods were regular for the first three months, but I am now experiencing irregular periods again. Why is this happening, and what should I do?

Chandrakanta Jena

Chandrakanta Jena

Pharm D

Diane 35 (Cyproterone and Ethinylestradiol) can help regulate periods while you are taking it, but irregular bleeding can sometimes occur even after a few months of treatment. This may happen due to missed or delayed tablets, changes in hormones, stress, weight changes, thyroid problems, PCOS, or other underlying conditions. Normoz DS may support hormonal and metabolic health, particularly in PCOS (polycystic ovary syndrome), but it does not always prevent irregular periods. Continue Diane 35 only as prescribed and take it consistently at the same time each day. Do not change the dose or stop it without medical advice. If irregular bleeding continues, becomes heavy, or occurs with severe pain, consult your doctor or gynaecologist. The doctor may recommend a pregnancy test, blood tests, or an ultrasound to identify the cause and adjust your treatment if needed.

I have had irregular periods due to PCOS for the last 3 years. My doctor prescribed Diane 35 Tablet for 3 months, but I read that it is mainly used for acne and excess hair growth. I do not have these symptoms, only irregular periods. Could you please clarify whether this tablet is still appropriate and safe for treating my condition?

Chandrakanta Jena

Chandrakanta Jena

Pharm D

Diane 35 Tablet contains ethinylestradiol and cyproterone acetate and is commonly used in women with PCOS (polycystic ovary syndrome). Although it is often prescribed for acne and excess hair growth, it is also helpful in regulating irregular periods. In PCOS, hormonal imbalance can cause unpredictable menstrual cycles, and this medicine works by balancing hormones, reducing male hormone effects, and helping restore a more regular cycle. Even if you do not have acne or unwanted hair growth, your doctor may prescribe it mainly for cycle regulation and to protect the uterine lining from long periods without bleeding. It is generally safe when used under medical supervision, but like all hormonal medicines, it may have side effects such as nausea, breast tenderness, mood changes, or a small risk of blood clots in some women. It is important to take it exactly as advised by your doctor and attend follow-up visits to monitor your response and ensure safety.

Is Diane 35 safe for PCOS patients, and how long can it be taken?

Y. Lakshmi Thulasi

Y. Lakshmi Thulasi

Pharm-D (Post baccalaureate)

Diane 35 can be used for PCOS to control menstruation and lessen androgen symptoms, but its safety depends on each person's health because it may have adverse effects including blood clots. Instead of long-term continuous use, doctors typically prescribe it for a few months to a year with frequent monitoring.

I have been bleeding for only one day during my periods for the past two months. I want to know the reason. I am currently taking Diane 35, but the flow is very slow. Please advise.

G.santoshini Reddy

G.santoshini Reddy

M Pharmacy (Pharmaceutics)

Very light or only one day of bleeding for two months can happen due to hormonal changes, and Diane-35 itself can make periods lighter. Stress, weight changes, thyroid problems, or conditions like PCOS can also affect flow. Do not stop Diane-35 on your own; please consult a gynaecologist for evaluation.
health query

Have a query?

How Soon It Starts Working

The time required for Diane 35 Tablet to start to work: The time required for Diane 35 Tablet to show its action is not clinically established.

The time for which the effects of Diane 35 Tablet last: The duration of action for Diane 35 Tablet is not clinically established.

What if you forget to take Diane 35 Tablet

If you miss a dose of Diane 35 Tablet , take it within the next 12 hours. If it has been more than 12 hours, skip the missed dose and take the next dose at the scheduled time.

Storage

•Store Diane 35 Tablet at room temperature, ideally between 20°C and 25°C (68°F to 77°F). •Keep the tablets in their original blister packaging to protect them from moisture and direct light.

Drug Warnings

  • Watch for blood clot symptoms: This medication carries a small but serious risk of blood clots. Seek immediate medical care if you experience sudden chest pain, shortness of breath, or painful swelling in one leg.
  • Plan ahead for surgeries: If you are scheduled for a major surgery or will be immobilized for a long period, tell your doctor. You may need to stop taking Diane 35 Tablet temporarily to reduce your risk of blood clots.
  • Do not use duplicate contraception: Diane 35 Tablet acts as an oral contraceptive. Do not take other hormonal birth control pills, patches, or vaginal rings at the same time.
  • Attend regular health checkups: Your doctor will likely want to check your blood pressure, weight, and perform regular physical exams while you are taking this medication.
  • Do not share this medicine: This medication has been prescribed specifically for you based on your hormonal profile. Sharing it with others can be highly dangerous.
     

Drug-Drug Interactions

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Drug-Drug Interaction Summary:

  • Epilepsy and seizure medications (such as carbamazepine, phenytoin, or phenobarbital): These can speed up the removal of Diane 35 Tablet from your body, making it less effective.
  • Certain antibiotics and tuberculosis medications (such as rifampicin): These can reduce the therapeutic effect and contraceptive protection of Diane 35 Tablet .
  • Herbal supplements: Taking them can significantly lower the effectiveness of this medicine and lead to breakthrough bleeding.
Ethinylestradiol + CyproteroneTranexamic acid
Critical
Ethinylestradiol + CyproteroneGriseofulvin
Severe

Drug-Drug Interactions

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Ethinylestradiol + CyproteroneTranexamic acid
Critical
How does the drug interact with Diane 35 Tablet:
Coadministration of Tranexamic acid with Ethinylestradiol and Cyproterone may increase the risk of blood clot formation.

How to manage the interaction:
Taking Tranexamic acid with Ethinylestradiol and Cyproterone is avoided, as it can lead to an interaction, but can be taken if a doctor has prescribed it. However, if you suffer from chest discomfort, shortness of breath, blood in the urine, or swelling in your arms and legs, consult a doctor immediately. Do not stop using any medications without talking to a doctor.
Ethinylestradiol + CyproteroneGriseofulvin
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of Griseofulvin with ethinyl estradiol + Cyproterone may reduce blood levels and the effects of ethinyl estradiol.

How to manage the interaction:
Although taking Griseofulvin with ethinyl estradiol + Cyproterone can result in an interaction, it can be taken if a doctor has suggested it. Inform a doctor if you experience unusual bleeding or your symptoms are no longer controlled. Do not stop using any medications without a doctor's advice.
Ethinylestradiol + CyproteronePhenobarbital
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of Phenobarbital with Diane 35 Tablet can reduce the levels and effects of ethinylestradiol.

How to manage the interaction:
Although taking Phenobarbital with Diane 35 Tablet can result in an interaction, it can be taken if a doctor has prescribed it. Contact your doctor if you experience any hot flashes, vaginal dryness, or irregular bleeding. Do not stop using any medications without talking to a doctor.
Ethinylestradiol + CyproteronePrimidone
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of Primidone with Diane 35 Tablet may decrease the blood levels and effects of ethinylestradiol.

How to manage the interaction:
Although there is an interaction of Primidone with Diane 35 Tablet, it can be taken if prescribed by a doctor. Contact your doctor if you experience any hot flashes, vaginal dryness, or irregular bleeding. Do not discontinue any medications without consulting a doctor.
Ethinylestradiol + CyproteroneOxcarbazepine
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of Oxcarbazepine with Diane 35 Tablet can reduce the blood levels of ethinylestradiol.

How to manage the interaction:
Although taking Oxcarbazepine with Diane 35 Tablet can result in an interaction, it can be taken if a doctor has prescribed it. Contact your doctor if you experience any hot flashes, vaginal dryness, or irregular bleeding. Do not discontinue any medications without consulting a doctor.
Ethinylestradiol + CyproteronePomalidomide
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of Pomalidomide with Diane 35 Tablet can increase the risk of developing blood clots.

How to manage the interaction:
Although there is a possible interaction of Pomalidomide with Diane 35 Tablet, you can take these medicines if prescribed by a doctor. However, if you experience chest pain, difficulty breathing, coughing up blood, swelling in an arm or leg, or weakness on one side of the body, consult a doctor immediately. Do not stop using any medications without a doctor's advice.
Ethinylestradiol + CyproteronePhenytoin
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of Phenytoin with Diane 35 Tablet may lower ethinyl estradiol levels in the blood and its effects. This can increase the risk of unusual bleeding or unexpected pregnancy.

How to manage the interaction:
Although taking Phenytoin with Diane 35 Tablet can result in an interaction, it can be taken if a doctor has prescribed it. Contact your doctor if you experience any hot flashes, vaginal dryness, or irregular bleeding. Do not stop using any medications without a doctor's advice.
Ethinylestradiol + CyproteroneRifampicin
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of Rifampicin with Ethinylestradiol and Cyproterone can reduce the blood levels and effects of ethinylestradiol.

How to manage the interaction:
Although there is an interaction of Rifampicin with Ethinylestradiol and Cyproterone, it can be taken if prescribed by a doctor. Contact your doctor if you experience any hot flashes, vaginal dryness, or irregular bleeding. Do not discontinue any medicine without consulting a doctor.
Ethinylestradiol + CyproteroneCarbamazepine
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of carbamazepine with ethinylestradiol and Cyproterone may reduce the effects of ethinylestradiol, which might increase the risk of unplanned pregnancy.

How to manage the interaction:
Although taking carbamazepine with ethinylestradiol and Cyproterone can result in an interaction, it can be taken if a doctor has prescribed it. However, if you experience any unusual symptoms contact a doctor immediately. Do not stop using any medications without talking to a doctor.
Ethinylestradiol + CyproteroneDabrafenib
Severe
How does the drug interact with Diane 35 Tablet:
Coadministration of Dabrafenib with Ethinylestradiol and Cyproterone can reduce the blood level of Ethinylestradiol, which can lead to low treatment outcomes.

How to manage the interaction:
There may be a possibility of interaction between Dabrafenib with Ethinylestradiol and Cyproterone, but it can be taken if prescribed by a doctor. If you experience symptoms such as hot flashes, vaginal dryness, or irregular bleeding, contact your doctor immediately. Do not discontinue any medications without consulting a doctor.

Drug-Food Interactions

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Drug-Food Interaction Summary:

  • Grapefruit juice: Consuming large amounts of grapefruit juice may increase the concentration of hormones in your blood, potentially increasing the risk of side effects.
No Drug - Food interactions found in our database. Some may be unknown. Consult your doctor for what to avoid during medication.

Drug-Food Interactions

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FAQs

Diane 35 Tablet is used to treat moderate to severe symptoms of PCOS, particularly androgen-sensitive acne and hirsutism (excess hair growth) in women of reproductive age. It works by reducing the effects of male hormones (androgens), which contribute to these symptoms.
Diane 35 Tablet works by blocking the production of androgens (male hormones) in the ovaries.
Diane 35 Tablet is also a hormonal contraceptive; it should not be used in combination with other hormonal contraceptives, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception.
Diane 35 Tablet does not protect against sexually transmitted diseases like HIV or Chlamydia. Only condoms can help do this.
Avoid using sunbeds or sunlamps and prolonged sunbathing whilst on treatment with Diane 35 Tablet as it might increase the chance of chloasma (patchy discolouration of the skin).
Diane 35 Tablet should be swallowed as a whole with water; do not crush or chew it. The dose will be determined by the doctor based on your condition.
If you miss a dose of Diane 35 Tablet , take it within the next 12 hours. If it has been more than 12 hours, skip the missed dose and take the next dose at the scheduled time.
Repeat the dose if you have vomited within 3-4 hours of taking Diane 35 Tablet . If it has been more than 4 hours, take the next dose at the scheduled time.
Yes, Diane 35 Tablet works as an oral contraceptive by preventing ovulation and reducing the likelihood of pregnancy. However, it is prescribed primarily for women with PCOS who require treatment for androgen-related symptoms such as acne or excess hair growth, rather than solely for contraception.
Diane 35 Tablet may cause nausea, abdominal pain, headache, weight gain and mood changes. Most of these side effects may not require medical attention and resolve gradually over time. However, you are advised to consult the doctor if the side effects persist or worsen.
Improvement in acne may begin within a few weeks of starting treatment. However, hormonal treatments generally require consistent use for several months, and it may take 3 to 6 months to experience the full benefits. Continue taking the medicine as prescribed and consult your doctor if you do not notice improvement after several months.
Some women may experience minor weight changes or fluid retention when they start taking Diane 35 Tablet . This is usually temporary as your body adjusts to the hormones. If you notice rapid or significant weight gain, talk to your doctor.
Spotting or breakthrough bleeding between periods is common during the first few months of taking Diane 35 Tablet . If the bleeding is heavy, lasts for more than a few days, or occurs after you have been taking the medicine for several months, talk to your doctor.
You should highly avoid smoking while taking Diane 35 Tablet . Smoking significantly increases the risk of serious cardiovascular side effects, including blood clots, heart attacks, and strokes, particularly in women over the age of 35. Talk to your doctor for support with smoking cessation.
No, you must not take Diane 35 Tablet if you are pregnant or planning to become pregnant. If you suspect you might be pregnant while taking this medication, stop taking it immediately and talk to your doctor.
While there is no direct interaction between alcohol and Diane 35 Tablet , excessive alcohol intake can affect your liver function and may increase some side effects like headaches or nausea. It is always best to consume alcohol in moderation. Talk to your doctor if you have concerns about alcohol use.
You must inform your surgeon or doctor that you are taking Diane 35 Tablet well in advance of any planned surgery. Because of the risk of blood clots during periods of inactivity, you may need to stop taking the medication several weeks before and after the procedure. Talk to your doctor to plan this safely.

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Country of origin

India

Manufacturer/Marketer address

Zydus Tower, Satellite Cross Roads, Ahmedabad – 380015, Gujarat, India.

Therapeutic Class

[MISCELLANEOUS]

Habit Forming

No
Other Info - DIA0016
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