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Rosen 28 0.030 mg/3 mg (Tablet)

Manufactured by: Incepta Pharmaceuticals Ltd.

Drospirenone + Ethinylestradiol Similar medicine

Rosen 28 is indicated for

  • Acne
  • Oral contraception
  • Premenstrual dysphoric disorder.

Precautions and warnings

This medicine may increase the risk of breast cancer, blood clots, and problems with blood sugar control. It can also cause high potassium levels in people with adrenal gland problems and may affect blood fats like triglycerides and cholesterol. Rarely, it can cause blood clots in the blood vessels of the eye—stop using it right away if you notice swelling in the eye or eye blood vessel problems. Use caution if you have depression, a history of migraines, or risk factors for heart disease, or if you have conditions made worse by fluid retention. The risk of gallbladder disease goes up with higher doses. If you smoke and are over 35, this medicine increases your risk of heart and blood vessel problems even more. You should stop this medicine four weeks before and for two weeks after any planned surgery that increases your risk of blood clots, or if you will be immobile for a long time. Do not use during breastfeeding.

Side-effects

  • Enlarged abdomen
  • abdominal pain
  • diarrhoea
  • dyspepsia
  • gastroenteritis
  • nausea
  • tooth disorder
  • vomiting
  • wt gain. Depression
  • dizziness
  • emotional lability
  • fever
  • headache
  • migraine
  • nervousness
  • pain. Acne
  • pruritus
  • rash. Amenorrhoea
  • breast pain
  • dysmenorrhoea
  • hyperlipidaemia
  • intermenstrual bleeding
  • reduced libido
  • irregular menstrual cycles. Bronchitis
  • cough
  • pharyngitis
  • rhinitis
  • sinusitis
  • upper respiratory infection.

Drug Interactions

There is a higher risk of high potassium levels (hyperkalaemia) if this medication is taken with ACE inhibitors, angiotensin II receptor blockers, aldosterone blockers, potassium supplements, or NSAIDs. Aminoglutethimide may speed up the breakdown of progestins in the liver. The risk of serious body-wide acidosis also goes up if taken with ammonium chloride. Certain medicines—like aprepitant, topiramate, rifampin, or protease inhibitors—can lower the amount of this medication in the blood.

The effectiveness of this drug can also be reduced if taken with acitretin, carbamazepine, felbamate, oxcarbazepine, phenobarbital, phenytoin, topiramate, barbiturates, griseofulvin, or modafinil. Estrogens can slow down how quickly benzodiazepines are removed from the body. Taking this medicine may raise the levels of corticosteroids, ciclosporin, tizanidine, voriconazole, and selegiline in the blood. It may also make blood thinners (coumarin derivatives) less effective, so using them together is not recommended. Finally, it may reduce how well protease inhibitors and lamotrigine work.

Contraindications

**Do not use in the following cases:**
- Pregnancy
- Unexplained abnormal genital bleeding
- Kidney or liver problems, or liver tumors
- Adrenal gland problems
- Jaundice during pregnancy, or jaundice caused by previous use of birth control pills
- Major surgery with long periods of bed rest
- Heavy smoking (more than 15 cigarettes a day) in people over 35
- A history of blood clots in the legs (thrombophlebitis) or lungs, or other blood clotting disorders
- Recent (within the past year) or active heart attack, stroke, or other serious heart or blood vessel diseases
- Severe high blood pressure or heart valve disease with risk of blood clots
- Diabetes with blood vessel problems
- Severe headaches or migraines with specific neurological symptoms
- Known or suspected breast cancer, uterine cancer, or other cancers that depend on estrogen

Mode of actions

Ethinylestradiol is a man-made form of estrogen, and drospirenone is a type of progestogen that also helps reduce water retention and block certain male hormones. Together, these hormones are used in combined oral contraceptive pills. These pills work mainly by stopping the release of hormones (gonadotropins) that trigger ovulation. Additionally, they make the mucus in the cervix thicker, making it harder for sperm to enter the uterus, which helps prevent pregnancy even if an egg is released.

Dosage & Administration

Adult: PO OC; Premenstrual dysmorphic disorder 1 tab/day for 21 days followed by 7 pill-free days before starting on a new pack. Take dose at the same time each day. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime.

Renal impairment:
CrCl (ml/min)

Pregnancy & Lactation

This medicine must not be used during pregnancy. It can be absorbed through the skin and lungs caused can damage your unborn child’s organs and cause congenital disabilities. Strict two effective types of birth control starting one month before and during treatment and for three years after stopping this medicine. Discuss with your doctors if you are not sure which types of birth control are effective for you. You must need to take pregnancy tests regularly during your treatment with this medicine and for at least three years after taking this medicine. If it seems that you do become pregnant stop taking this medicine and call your doctor immediately. If you really become pregnant, miss a menstrual period, or have sex without using two forms of birth control. In some cases, your doctor can prescribe emergency contraception to prevent pregnancy. People on this medicine should not donate blood during the treatment and for three years afterward.

This medicine is also contraindicated breast milk. Breastfeeding is not recommended while using this medication and for three years afterward.

Pack Size & Price

28's pack Price : ৳399

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Novelon Lite 3 mg + 20 mcg (Tablet)

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Rosen 28 0.030 mg/3 mg (Tablet)

Manufactured by: Incepta Pharmaceuticals Ltd.

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There are few similar medicines of Rosen 28 are manufactured by other companies using the same ingredients. Although, it would be good if you are able to use the same medicine, which has been prescribed by your Doctor. Due to availability in the local market, you can try others. Please make sure and contact your Doctor first about alternatives.