Cerelle Uses

• Cerelle indications
• Uses of Cerelle in details
• Cerelle description
• Cerelle dosage
• Cerelle interactions
• Cerelle side effects
• Cerelle contraindications

Cerelle indications

Oral contraception.

Cerelle, like all hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Uses of Cerelle in details

Cerelle is a type of progestetrone used to prevent pregnancy especially in women not able to tolerate estrogens or are breast feeding.

Cerelle description

Each film-coated tablet also contains the following excipients: Lactose <65 mg. Tablet Core: Anhydrous colloidal silica, all-rac-α-tocopherol, lactose monohydrate, maize starch, povidone, stearic acid. Film Coat: Hypromellose, macrogol 400, talc, titanium dioxide (E171).

Cerelle dosage

The Cerelle pack contains 28 tablets. Arrows are printed on the front side of the pack, between the tablets. At the back side of the pack, the days of the week are printed on the foil. Each day corresponds to 1 tablet.

Taking Cerelle: When starting a new pack of Cerelle, the woman should take a tablet from the top row. She should not start with just any tablet. For example, if starting on a Wednesday, she must take the tablet from the top row marked (at the back) with "WED". She should continue to take one tablet a day until the pack is empty, always following the direction indicated by the arrows. By looking at the back of the pack, she can easily check if she has already taken the tablet for a particular day.

If bleeding occurs during the use of Cerelle, continue to take the tablets as usual. When a pack is empty, the patient should start with a new pack on the next day, thus without interruption and without waiting for a bleed.

Starting on the First Pack of Cerelle: No Preceding Hormonal Contraceptive Used in the Past Month: The first Cerelle tablet should be taken on the first day of the woman's period. There is no need to take extra contraceptive precautions.

The woman can also start on days 2 to 5 of her period, but in that case, must make sure to use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.

Switching from a Combined Pill, Vaginal Ring or Transdermal Patch: Cerelle can be started on the day after taking the last tablet from the woman's present pill pack, or on the day of removal of vaginal ring or patch (this means no tablet-, ring- or patch-free break). If her present pill pack also contains inactive tablets, she can start Cerelle on the day after taking the last active tablet (if she is not sure when this is, she should ask the physician or pharmacist). If she follows these instructions, she need not use an additional contraceptive method.

At the latest, the woman can start the day following the tablet-, ring-, patch-free break or placebo tablet interval of her present contraceptive. If she follows these instructions, an additional contraceptive method (barrier method) for the first 7 days of tablet-taking during the first cycle is necessary.

Switching from Another Progestogen-Only Pill (Mini-Pill): The woman may stop taking the mini-pill any day and start with Cerelle right away. Extra contraceptive precautions are not necessary.

Switching from an Injectable or Implant or a Progestogen-Releasing Intrauterine Device (IUD): Cerelle should be started when the next injection is due or on the day that the implant or IUD is removed. Extra contraceptive precautions are not necessary.

Following Delivery: The woman can start Cerelle between 21 to 28 days after the birth of the baby. If she decides to start later, an additional contraceptive method (barrier method) during the first cycle for the first 7 days of tablet-taking is necessary. However, if intercourse has already occurred, pregnancy should be excluded before starting Cerelle use. Additional information for breast-feeding women can be found in Use in Pregnancy & Lactation. The physician can also advise the patient.

Following a Miscarriage or Abortion: Consult the physician.

Management of Missed Tablets: If the woman is less than 12 hours late in taking a tablet, the reliability of Cerelle is maintained. The missed tablet should be taken as soon as she remembers and the next tablets should be taken at the usual times.

If the woman is more than 12 hours late in taking a tablet, the reliability of Cerelle may be reduced. The more consecutive tablets missed, the higher the risk that the contraceptive efficacy is decreased. The last missed tablet should be taken as soon as she remembers and the next tablets should be taken at the usual times. An additional contraceptive method (barrier method) should be used for the next 7 days of tablet-taking.

If one or more tablets are missed in the 1st week of tablet-intake and the woman had intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. Consult the physician for advice.

Advice in Case of Gastrointestinal Disturbances (e.g., Vomiting, Severe Diarrhea): Follow the advise in the previous text if vomiting within 3-4 hours after taking Cerelle occurs, or if the woman has severe diarrhoea, Cerelle may not have been completely absorbed.

Stopping Cerelle Therapy: The woman can stop taking Cerelle at any time. She is no longer protected against pregnancy once medication is discontinued.

Administration: The tablets should be taken at about the same time each day. The tablet should be swallowed whole with water. She may have some bleeding during the use of Cerelle, but she must continue to take the tablets as normal. When a pack is empty, she must start with a new pack of Cerelle on the next day-thus without interruption and without waiting for a bleed.

Cerelle interactions

Interactions between OCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with POCs).

Hepatic Metabolism: Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones [eg, hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), primidone, carbamazepine, rifampicin; and possibly also oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum)].

Women on treatment with any of these drugs should temporarily use a barrier method in addition to Cerelle or choose another method of contraception. The barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. For women on long-term therapy with hepatic enzyme inducers, a non-hormonal method of contraception should be considered.

During treatment with medical charcoal, the absorption of the steroid in the tablet may be reduced and thereby the contraceptive efficacy. In such an event, the advice concerning missed tablets as given in Management of Missed Pills under Dosage & Administration is applicable.

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (eg, cyclosporine) or decrease.

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

Laboratory Tests: Data obtained with COCs have shown that contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins eg, corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestogen-only contraceptives is not known.

Incompatibilities: Not applicable.

Cerelle side effects

The most commonly reported adverse effects in the clinical trials with Cerelle (>2.5%) were bleeding irregularities, acne, mood changes, breast pain, nausea and weight increase. The undesirable effects mentioned as follows have been judged by the investigators as having an established, probable or possible link to the treatment.

Infections and Infestations: Uncommon (<1/100, ≥1/1000): Vaginal infection.

Psychiatric Disorders: Common (≥1/100): Altered mood, decreased libido.

Nervous System Disorders: Common: Headache.

Eye Disorders: Uncommon: Contact lens intolerance.

Gastrointestinal Disorders: Common: Nausea. Uncommon: Vomiting.

Skin and Subcutaneous Tissue Disorders: Common: Acne. Uncommon: Alopecia. Rare (<1/1000): Rash, urticaria, erythema nodosum.

Reproductive System and Breast Disorders: Common: Breast pain, irregular menstruation, amenorrhea. Uncommon: Dysmenorrhea, ovarian cyst.

General Disorders and Administration Site Condition: Uncommon: Fatigue.

Investigations: Common: Increased weight.

Breast discharge and on rare occasions, ectopic pregnancies have been reported with the use of Cerelle during post-marketing surveillance.

In women using COCs, a number of (serious) adverse effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone dependent tumors (eg, breast cancer) and chloasma, some of which are discussed in more detail in Precautions.

Cerelle contraindications

Progestogen-only contraceptives should not be used in the presence of any of the conditions listed as follows. Should any of the conditions appear for the first time during the use of Cerelle, the product should be stopped immediately.

Hypersensitivity to Cerelle or to any of the excipients of Cerelle.

Known or suspected pregnancy.

Active venous thromboembolic disorder.

Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

Known or suspected sex steroid-sensitive malignancies.

Undiagnosed vaginal bleeding.

Active ingredient matches for Cerelle:

Desogestrel in United Kingdom.

References

1. DailyMed. "DESOGESTREL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "DESOGESTREL". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "DESOGESTREL". http://www.drugbank.ca/drugs/DB00304 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology