Dienogest - Oral

Dienogest is used to treat endometriosis (abnormal growth of tissues outside the womb).

Take Dienogest exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

You may take this medicine with or without food. Try to take it at the same time each day.

If you vomit or experience diarrhoea within 3-4 hours after taking Dienogest, repeat the dose and return to your normal dosing schedule.

Dienogest must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.

Alert your doctor if you have the following conditions:

• unexplained vaginal bleeding
• blood clotting disorder
• known or suspected cancer that is affected by sex hormones e.g. cancer of the breast or genital organs
• current or history of heart or blood vessel problems e.g. recent heart attack
• recent stroke
• diabetes with blood vessel damage
• non-cancerous or cancerous liver tumour
• current or history of severe liver disease

as Dienogest may not be suitable for you.

Do not take this medicine if you are pregnant or planning to have a baby soon. If you become pregnant while on Dienogest therapy, alert your doctor immediately. This medicine may cause harm to your unborn child.

Do not take Dienogest if you are breastfeeding.

Inform your doctor if you have the following conditions:

• history of chloasma gravidarum (brown patches of skin usually on the face or neck during pregnancy)
• history of ectopic pregnancy (a pregnancy in which the fetus develops outside of the womb)
• at risk of blood clotting disorders e.g. personal or family history of blood clotting disorders, obesity
• at risk of osteoporosis (thinning and weakening of bones)
• high blood pressure
• diabetes or history of diabetes during previous pregnancy
• history of depression
• history of jaundice (yellowing of the skin and whites of the eyes) or itching all over the body during previous pregnancy or due to the use of sex hormones

Inform your doctor if you are a smoker. Your doctor may advise you to stop smoking while taking Dienogest.

If you are going to have certain laboratory tests or an operation, including minor surgery and dental work, inform your doctor or dentist that you are taking this medicine.

You must not use any birth control medicines containing hormones while taking Dienogest. If you want to prevent pregnancy, use non-hormonal methods of birth control (e.g. condoms). You may wish to discuss other reliable methods of birth control with your doctor.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy tests must be done before treatment to know if this medicine is suited for you to take.
• Monitoring of blood pressure, signs and symptoms of depression and pain in the lower abdomen or pelvic area may also be needed.

Dienogest may cause any of the following side effects: nausea, vomiting, stomach pain, stomach wind, headache, weakness, pimple, weight gain, back pain, hair loss, and changes in bleeding or menstrual pattern.

If you tend to develop chloasma, you should avoid exposure to the sun or UV rays while taking this medicine. Apply sunscreen and wear protective clothing when going outdoors.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• shortness of breath, chest pain, cough which may contain blood, trouble speaking or swallowing
• pain, swelling and tenderness in your leg accompanied by redness and warmth
• pelvic pain or pressure
• unusual changes in mood or behaviour (being too depressed)
• yellowing of the skin or eyes, abdominal pain, dark coloured urine, tiredness, swelling in the legs and ankles

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor and pharmacist if you are taking any of these medicines:

• medicines for epilepsy (fits or seizures) e.g. phenobarbital, primidone, phenytoin, carbamazepine, felbamate, oxcarbazepine
• medicines to treat fungal infection e.g. ketoconazole, griseofulvin
• erythromycin (antibiotic)
• rifampicin (medicine used to treat TB, a lung infection known as tuberculosis)
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Dienogest.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Avoid excessive consumption of grapefruit or grapefruit juice (more than 1 litre a day).

Store in a cool, dry place away from the reach of children.

Protect from light.

Medicines must not be used past the expiry date.