Patient leaflet - Zalkya 2 mg film-coated tablets

1. WHAT DIENOGEST STRAGEN IS AND WHAT IT IS USED FOR

Dienogest Stragen is a medicine used for the treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb). Dienogest Stragen contains a hormone, the progestogen dienogest.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIENOGEST STRAGEN

DO NOT take Dienogest Stragen if you:

are suffering from a blood clot (thromboembolic disorder) in your veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See also “Dienogest Stragen and venous blood clots” below;
have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke or heart disease which causes a reduced blood supply (angina pectoris). See also "Dienogest Stragen and arterial blood clots" below;
have diabetes with blood vessel damage;
have or have ever had severe liver disease (and your liver function values have not returned to normal); Symptoms of liver disease may be yellowing of the skin and/or itching of the whole body;
have or have ever had a benign or malignant liver tumour;
suffer or have ever suffered, or if it is suspected that you suffer from a malignant sex-hormone dependent tumour such as cancer of the breast or the genital organs;
have any unexplained vaginal bleeding;
are allergic (hypersensitive) to dienogest or any of the other ingredients of this medicine (see section 6).

If any of these conditions appear for the ﬁrst time while using Dienogest Stragen, stop taking it at once and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dienogest Stragen.

You must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking Dienogest Stragen.

Dienogest Stragen is NOT a contraceptive. If you want to prevent pregnancy, you should use condoms or other non- hormonal contraceptive precautions.

In some situations you need to take special care while using Dienogest Stragen, and your doctor may need to examine you regularly.

Tell your doctor if any of the following conditions applies to you: If you:

have ever had a blood clot (venous thromboembolism) or anyone in your immediate family has had a blood clot at a relatively early age;
have a close relative who has had breast cancer;
have ever suffered from depression;
have high blood pressure or develop high blood pressure while taking Dienogest Stragen;
develop a liver disease while taking Dienogest Stragen. Symptoms may include yellowing of the skin or eyes or itching all over your body. Inform your doctor also if such symptoms occurred during a previous pregnancy;
have diabetes or had diabetes temporarily during previous pregnancy;
have ever had chloasma (golden-brown patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation;
suffer from pain in your lower abdomen while taking Dienogest Stragen.

While taking Dienogest Stragen your chance of becoming pregnant is reduced because Dienogest Stragen may affect ovulation. If you become pregnant while taking Dienogest Stragen you are at a slightly increased risk of having an extrauterine pregnancy (the embryo develops outside the womb). Tell your doctor before you start taking Dienogest Stragen, if you had an extrauterine pregnancy in the past or have an impaired function of the Fallopian tubes.

Dienogest Stragen and serious uterine bleeding

Uterine bleeding, for example in women with a condition where the mucous membrane of your uterus (endometrium) grows into the muscle layer of your uterus, called adenomyosis uteri or benign

tumours of the womb sometimes called uterine ﬁbroids (uterine leiomyomata), may become worse with the use of Dienogest Stragen.

If bleeding is heavy and continuous over time, this may lead to low red blood cell levels (anemia), which may be severe in some cases. In the event of anemia, you should discuss with your doctor if you should stop taking Dienogest Stragen.

Dienogest Stragen and changes in bleeding pattern

Most women treated with Dienogest Stragen experience changes in their menstrual bleeding pattern (see section 4, possible side effects).

Dienogest Stragen and venous blood clots

Some studies indicate that there may be a slight, but not statistically signiﬁcant, increased risk of a blood clot in the legs (venous thromboembolism) associated with the use of preparations with progestogens like Dienogest Stragen. Very rarely, blood clots may cause serious permanent disabilities or may even be fatal.

The risk of a venous blood clot increases:

with increasing age;
if you are overweight;
if you or one of your close relatives had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age;
if you must have surgery, if you have had a serious accident or if you are immobilized for a long time. It is important to tell your doctor in advance that you are using Dienogest Stragen as the treatment may have to be stopped. Your doctor will tell you when to start Dienogest Stragen again. This is usually about two weeks after you are back on your feet.

Dienogest Stragen and arterial blood clots

There is little evidence for an association between preparations with progestogens like Dienogest Stragen and an increased risk of a blood clot in, for example, the blood vessels of the heart (heart attack) or the brain (stroke). In women with hypertension the risk of stroke may be slightly enhanced by these preparations.

The risk of an arterial blood clot increases:

if you smoke. You are strongly advised to stop smoking when you use Dienogest Stragen, especially if you are older than
35 years;
if you are overweight;
if one of your close relatives had a heart attack or stroke at a young age;
if you have high blood pressure.

Talk to your doctor before taking Dienogest Stragen.

Stop taking Dienogest Stragen and contact your doctor immediately if you notice possible signs of a blood clot, such as:

severe pain and/or swelling in one of your legs;
sudden severe pain in the chest which may reach the left arm;
sudden breathlessness;
sudden cough without an obvious cause;
any unusual, severe or long-lasting headache or worsening of migraine;
partial or complete blindness or double vision;
difficulty in speaking or inability to speak;
giddiness or fainting;
weakness, strange feeling, or numbness in any part of the body.

Dienogest Stragen and cancer

It is not clear from the data currently available whether or not Dienogest Stragen increases the risk of breast cancer. Breast cancer has been observed slightly more often in women taking hormones compared to those not taking hormones, but it is not known whether this is caused by the treatment. For example, it may be that more tumours are detected and detected earlier in women taking hormones because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the hormone treatment. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.

In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in women taking hormones. Contact your doctor if you have unusually severe stomach pain.

Dienogest Stragen and osteoporosis

Changes in bone mineral density (BMD)

The use of Dienogest Stragen may affect the strength of the bone of adolescents (12 to under 18 years). If you are under 18 your doctor will, therefore, carefully weigh the beneﬁts and risks of using Dienogest Stragen for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

If you use Dienogest Stragen, it will help your bones if you have an adequate intake of calcium and vitamin D either via your food or via supplements.

If you have an increased risk of getting osteoporosis (weakening of bones due to loss of bone minerals), your doctor will carefully weigh the risks and beneﬁts of treatment with Dienogest Stragen because Dienogest Stragen has a moderate suppressing effect on the production of oestrogen (another type of female hormone) by your body.

Children and adolescents

Dienogest Stragen is not for use in girls before menarche (ﬁrst menstrual bleeding).

The use of Dienogest Stragen may affect the strength of the bone

.../...

12328_A00

PACKAGE LEAFLET: INFORMATION FOR THE USER

Film-Coated Tablets
		dienogest

of adolescents (12 to under 18 years). If you are under 18 your doctor will, therefore, carefully weigh the beneﬁts and risks of using Dienogest Stragen for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

Other medicines and Dienogest Stragen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you are taking Dienogest Stragen.

Some medicines can have an inﬂuence on the blood levels of Dienogest Stragen and can make it less effective, or can cause undesirable effects.

These include:

medicines used for the treatment of:
- epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
- tuberculosis (e.g. rifampicin);
- HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
- fungal infections (griseofulvin, ketoconazole);
- the herbal remedy St. John’s wort.

Dienogest Stragen with drink

During Dienogest Stragen treatment, you should avoid drinking grapefruit juice, because this may increase the levels of Dienogest Stragen in your blood. This may increase the risk of getting side effects.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Dienogest Stragen, because Dienogest Stragen can affect the results of some tests.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Dienogest Stragen if you are pregnant or breast- feeding.

Driving and using machines

No effects on the ability to drive and use machines have been observed in users of Dienogest Stragen.

3. HOW TO TAKE DIENOGEST STRAGEN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For adults, the usual dose is 1 tablet per day.

The following statements apply to Dienogest Stragen unless otherwise prescribed by your doctor. Please follow these instructions, otherwise you will not fully beneﬁt from Dienogest Stragen.

You can start treatment with Dienogest Stragen on any day of your natural cycle.

Adults: take one tablet every day, preferably at the same time with some liquid as needed. When a pack is ﬁnished the next one should be started without interruption. Continue to take the tablets also on days of menstrual bleeding.

If you take more Dienogest Stragen than you should

There have been no reports of serious harmful effects from taking too many Dienogest Stragen tablets at one time. However, if you are concerned, contact your doctor.

If you forget to take Dienogest Stragen or suffer from vomiting or diarrhoea

Dienogest Stragen will be less effective if you miss a tablet. If you miss one or more tablets, take one tablet only as soon as you remember, and then continue next day taking the tablet at your usual time.

If you vomit within 3-4 hours of taking Dienogest Stragen or you have severe diarrhoea, there is a risk that the active substance in the tablet will not be taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea within 3-4 hours of taking Dienogest Stragen, you should take another tablet as soon as possible.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Dienogest Stragen

If you stop taking Dienogest Stragen, your original endometriosis symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are more common during the ﬁrst months after start of intake of Dienogest Stragen and usually disappear with continued use. You may also experience changes in your bleeding pattern, such as spotting, irregular bleeding or your periods may stop completely.

Common (affecting between 1 and 10 in every 100 users)

weight gain;
depressed mood, problems sleeping, nervousness, loss of
interest in sex, or changed mood;
- headache or migraine;
- nausea, abdominal pain, wind, swollen tummy or vomiting;
- acne or hair loss;
- back pain;
- breast discomfort, ovarian cyst or hot ﬂushes;
- uterine/vaginal bleeding including spotting;
- weakness or irritability.

Uncommon (affecting between 1 and 10 in every 1,000 users)

anemia;
weight loss or increase in appetite;
anxiety, depression or mood swings;
imbalance in the autonomic nervous system (controls unconscious bodily functions, e.g. perspiration) or disturbed attention;
dry eye;
tinnitus;
unspeciﬁc circulatory problems or uncommon palpitations;
low blood pressure;
shortness of breath;
diarrhoea, constipation, abdominal discomfort, inﬂammation of the stomach and intestines (gastrointestinal inﬂammation), inﬂammation of the gums (gingivitis);
dry skin, excessive sweating, severe itching of the whole body, male pattern hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitive response to light or problems with skin pigmentation;
pains in your bones, muscle spasms, pains and/or a sensation of heaviness in your arms and hands or legs and feet;
urinary tract infection;
vaginal thrush, dryness of the genital area, vaginal discharge, pelvic pain, atrophic inﬂammation of the genitals with discharge (atrophic vulvovaginitis), or a lump or lumps in the breast;
swelling due to ﬂuid retention.

Additional side effects in adolescents (12 to under 18 years): loss of bone density.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaﬂet. You can also report side effects directly via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. HOW TO STORE DIENOGEST STRAGEN

This medicinal product does not need a speciﬁc storage condition. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging after "EXP.:".

The expiry date refers to the last day of that month.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dienogest Stragen contains

The active substance is dienogest. Each tablet contains 2 mg dienogest.

The other ingredients are

Core: cellulose microcrystalline, pregelatinised maize starch, crospovidone, povidone K25, silica colloidal anhydrous, magnesium stearate

Film coating: AquaPolish white: hypromellose, hydroxypropyl- cellulose, cottonseed oil, hydrogenated, talc, titanium dioxide (E171)

What Dienogest Stragen looks like and contents of the pack

Dienogest Stragen tablets are white, round, 7.1 mm wide and 3.4 mm high ﬁlm coated tablets.

14 white ﬁlm-coated tablets are packed in PVC (250 µm)- Aluminium (20 µm) push-through-blister.

Two blisters of 14 tablets are then packed in a PET (Polyethylene Terephthalate)/ aluminium/ PE (Polyethylene) pouch, which protects tablets from humidity.

One or three pouches are packed in a carton box.

Pack sizes: 28 and 84 ﬁlm-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Stragen UK Ltd

Castle Court

41 London Road

Reigate

Surrey RH2 9RJ

Phone: +44 (0)1737 735029

Email: info@stragenuk.com

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

This leaﬂet was last revised in 02/2024.