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Product Information

What is Cyclen?

Cyclen refers to a group of prescription oral contraceptive drugs containing a combination of norgestimate and ethinyl estradiol as the active components. These are two female sex hormones used as contraceptives for the prevention of pregnancy and acne vulgaris in females age 15 years and above who have achieved menarche, desire contraception, and have no know contraindication to oral contraceptives. It is available as a single tablet in containing norgestimate and ethinyl estradiol in the following ratios:

0.180mg norgestimate and 0.035mg ethinyl estradiol;

0.215mg norgestimate and 0.035mg ethinyl estradiol;

0.250mg norgestimate and 0.035mg ethinyl estradiol.

It is manufactured by various pharmaceutical companies in Canada and the US, and it is available as a 21- or 28-day pack. The 28-day pack contains 21 active pills of the same color and 7 inactive pills of the same color, while the 21-day pack has 21 active pills.

Active ingredient

The active ingredients are norgestimate and ethinyl estradiol. These are female hormones that work in the body to prevent the release of eggs from the ovary (ovulation), by inducing changes in the body (cervical mucus and uterine lining), making it difficult for sperm to reach the uterus and fertilized the release eggs.

Conditions treated

• Prevention of pregnancy

Generic vs brand name

There are is a generic alternative called norgestimate and ethinyl estradiol.

Dosage information

Use your medication as directed by your healthcare professional. If you are not sure of how to, please check with your pharmacist or doctor. This medication can start being taken on a Sunday or from day 1 of your menstrual cycle.

21-day pack: 

• Take 1 tablet about the same time daily for 21 consecutive days and 7 days off the pill. You should not be off the pill for more than 7 days.

28-day pack: 

• Take 1 tablet about the same time daily for 28 consecutive days with no pill free days. The 7 inactive pills should be taken during your menstrual cycle. The first day of your menstrual cycle is day 1, and your doctor will decide on an appropriate day for you to start taking your contraceptive pills.

Side effects

• Sudden weakness or numbness on one side of the body
• Severe headache, problems with vision, speech, and confusion
• Chest pain
• A change in the severity or pattern of migraine headaches
• Nausea, itching, loss of appetite, clay-colored stools, upper stomach pain, dark urine, and jaundice (yellowing of the skin or eyes)
• Symptoms of depression (mood changes)
• Changes in weight
• Vaginal itching or discharge
• Changes in your menstrual periods
• Decreased sex drive

Warnings and precautions

Contraindications

• The use of Cyclen is contraindicated in patients who are hypersensitive to norgestimate and ethinyl estradiol or any of the excipients used in the formulation.

Precautions

• The risk of serious adverse effects on blood vessels and the heart increases with cigarette smoking and it increases with age in very prominent in users over the age of 35 years old.
• The use of oral contraceptives should be avoided in patients with a history of or actual blood clots.
• The use of oral contraceptives should be avoided in patients with a history of cerebrovascular disorders (stroke).
• This medication should be avoided in patients with impaired liver function (active or history of or actual malignant liver tumors).
• This medication should not be used during pregnancy.

Oral contraceptives do not protect against sexually transmitted infections.

Drug interactions

Using norgestimate and ethinyl estradiol with certain drugs can either potentiate their effects in the body or nullify them. Therefore, you should know the medicines you take and always remember to tell your healthcare provider when you are prescribed new medicine. Some drugs that may interact with norgestimate and ethinyl estradiol include, but are not limited to:

• Bosentan
• Alcohol
• Antibiotics or tuberculosis medications
• Medications used for the treatment of hepatitis C, HIV, or AIDS
• Phenobarbital
• Barbiturates
• Seizure medications.
• Dantrolene
• Lamotrigine
• Tizanidine
• Tranexamic acid
• Griseofulvin,
• Fluconazole
• Phenylbutazone
• Antihistamines
• Analgesics
• Antimigraine
• preparations
• Vitamin E
• Modafinil

Frequently asked questions

How to store Cyclen?

• Store away from direct sunlight and heat.
• Store at room temperature.
• Do not store in a humid place.
• Keep in a closed container.
• Keep out of the reach of children.

What if I overdose on Cyclen?

• If you accidentally overdose on Cyclen, seek immediate medical advice or call the Poison Control Helpline at 1-800-222-1222. Some symptoms of overdose may include nausea, vomiting, and vaginal bleeding.

What if I miss a dose of Cyclen?

• When a dose of the active tablet is missed, the missed dose/tablet should be taken as soon as possible then continue with the normal schedule.
• When 2 doses are missed in week 1 or 2 of the cycle, 2 tablets should be taken as soon as possible and another 2 tablets the next day then continue with the normal schedule.
• When 2 doses are missed in week 3 or 3 doses at any point in the cycle, people who started at day 1 should discard the current pack and start with a new pack that same day. For those who start on Sunday, they should take 1 tablet daily until Sunday then discard the pack and then start with a new pack.

Use additional contraceptive methods for up to 7 days whenever a dosed is missed.