Climodien 2/2 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Climodien 2 mg/2 mg coated tablets
estradiol valerate / dienogest
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Package leaflet contents
- What Climodien is and what it is used for
- What you need to know before starting to take Climodien
- How to take Climodien
- Possible side effects
- Storage of Climodien
- Contents of the pack and other information
1. What Climodien is and what it is used for
Climodien is indicated as hormone replacement therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. Climodien is used in postmenopausal women who have had their last natural menstrual period at least 12 months ago, and who still have their uterus.
Climodien is used for:
Relief of symptoms occurring after menopause
During menopause, the amount of oestrogen produced by a woman's body decreases. This may cause symptoms such as sudden feelings of heat in the face, neck and chest ("hot flushes"). Climodien relieves these postmenopausal symptoms. Climodien will only be prescribed to you if your symptoms are significantly affecting your daily life.
2. What you need to know before starting Climodien
Medical history and regular check-ups
The use of HRT carries risks that must be considered when deciding whether to start or continue treatment.
Experience with treating women who have premature menopause (due to ovarian insufficiency or surgical intervention) is limited. If you have premature menopause, the risks of using HRT may differ. Please consult your doctor.
Before starting (or restarting) HRT, your doctor will ask about your personal and family medical history. Your doctor may decide to perform a physical examination. This may include a breast examination and/or an internal examination, if necessary.
Once you have started taking Climodien, you should visit your doctor for regular check-ups (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing Climodien.
- Have regular breast examinations as recommended by your doctor.
Do not take Climodien
If any of the following apply to you. If you are unsure about any of the following points, consult your doctor before taking Climodien.
Do not take Climodien:
- If you have or have had breast cancer or suspect you may have it.
- If you have a cancer sensitive to estrogens, such as cancer of the inner lining of the uterus (endometrium), or suspect you may have it.
- If you have abnormal vaginal bleeding.
- If you have excessive thickening of the inner lining of the uterus (endometrial hyperplasia) that is untreated.
- If you have or have had a blood clot in a vein (thrombosis), such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
- If you have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
- If you currently have or have recently had a disease caused by blood clots in the arteries, such as heart attack, stroke, or angina pectoris.
- If you have or have had a liver disease and your liver function tests have not returned to normal.
- If you have a rare inherited blood disorder called "porphyria" passed from parent to child (hereditary).
- If you are allergic to estradiol valerate, dienogest, or any of the other ingredients of this medicine (listed in section 6).
If any of the above conditions occurs for the first time while you are taking Climodien, stop taking it immediately and consult your doctor without delay.
Warnings and precautions
Consult your doctor before starting to take Climodien.
When to be especially careful with Climodien
Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen during treatment with Climodien. If so, you should visit your doctor more frequently for check-ups:
- fibroids in the uterus
- growth of the inner lining of the uterus outside the uterus (endometriosis) or history of excessive growth of the inner lining of the uterus (endometrial hyperplasia)
- increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)")
- increased risk of developing an estrogen-sensitive cancer (for example, having a mother, sister, or grandmother who had breast cancer)
- high blood pressure
- a liver disorder, such as a benign liver tumor
- diabetes
- gallstones
- migraine or severe headaches
- an autoimmune disease affecting multiple organs (systemic lupus erythematosus, SLE)
- epilepsy
- asthma
- a condition affecting the eardrum and ear (otosclerosis)
- very high levels of fat in the blood (triglycerides)
- fluid retention due to heart or kidney problems
- hereditary and acquired angioedema.
Stop taking Climodien and contact your doctor immediately
If you experience any of the following conditions while taking HRT:
- any of the conditions listed in the section “Do not take Climodien”
- yellowing of the skin or whites of the eyes (jaundice). This may be a sign of liver disease
- swelling of the face, tongue, or throat and difficulty swallowing or hives accompanied by difficulty breathing, suggesting angioedema
- a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
- new-onset migraine-type headaches
- if you become pregnant
- if you notice signs of a blood clot, such as
- painful swelling and redness in the legs
- sudden chest pain
- difficulty breathing
For more information, see “Blood clots in a vein (thrombosis)”.
Note: Climodien is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you may need to use an additional contraceptive method to prevent pregnancy. Seek advice from your doctor.
HRT and cancer
Excessive thickening of the inner lining of the uterus (endometrial hyperplasia) and cancer of the inner lining of the uterus (endometrial cancer)
Taking HRT with estrogens alone increases the risk of excessive thickening of the inner lining of the uterus (endometrial hyperplasia) and cancer of the inner lining of the uterus (endometrial cancer). The progestogen in Climodien protects against this additional risk.
Irregular bleeding
You may experience irregular bleeding or spotting during the first 3–6 months of taking Climodien. However, if irregular bleeding:
- continues beyond the first 6 months
- starts after having taken Climodien for more than 6 months
- continues after stopping Climodien
consult your doctor as soon as possible.
Breast cancer
Available data show that the use of hormone replacement therapy (HRT) with combined estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The additional risk depends on how long you use HRT. The additional risk becomes evident after 3 years of use. After stopping HRT, the additional risk decreases over time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.
Comparison
Among women aged 50 to 54 years who are not using HRT, an average of 13 to 17 out of 1,000 will be diagnosed with breast cancer over a 5-year period.
Among women aged 50 who start estrogen-only HRT for 5 years, there will be between 16 and 17 cases per 1,000 women (i.e., between 0 and 3 additional cases).
Among women aged 50 who start combined estrogen-progestogen HRT for 5 years, there will be 21 cases per 1,000 women (i.e., 4–8 additional cases).
Among women aged 50 to 59 years not taking HRT, an average of 27 cases of breast cancer will be diagnosed per 1,000 women over a 10-year period.
Among women aged 50 who start estrogen-only HRT for more than 10 years, there will be 34 cases per 1,000 women (i.e., 7 additional cases).
Among women aged 50 who start combined estrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 women (i.e., 21 additional cases).
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Examine your breasts regularly. Consult your doctor if you notice any changes, such as:
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dimpling of the skin
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changes in the nipple
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any lump you can see or feel
In addition, you are encouraged to participate in screening mammography programs when offered. For screening mammograms, it is important that you inform the nurse/healthcare professional performing the X-ray that you are using HRT, as these medications can increase breast density, which may affect the mammogram result. Increased breast density may make it harder for mammograms to detect all lumps.
Ovarian cancer
Ovarian cancer is less common than breast cancer. The use of HRT with estrogen alone or combined estrogen-progestogen has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 years not using HRT, about 2 cases of ovarian cancer are observed per 2,000 women over a 5-year period. In women using HRT for 5 years, about 3 cases per 2,000 patients are observed (i.e., about 1 additional case).
Effect of HRT on the heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in veins is approximately 1.3 to 3 times higher in users of HRT compared to non-users, especially during the first year of use.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, difficulty breathing, fainting, or even death.
Your risk of developing a blood clot in a vein increases with age and if any of the following apply to you. Inform your doctor if any of these situations apply to you:
- inability to walk for a prolonged period due to major surgery, injury, or illness (see also section 3, “If you need to undergo surgery”)
- severe obesity (BMI > 30 kg/m²)
- a blood clotting disorder requiring long-term treatment with a medication used to prevent blood clots
- if any of your close relatives has ever had a blood clot in the leg, lung, or another organ
- systemic lupus erythematosus (SLE)
- cancer
For symptoms of a blood clot, see “Stop taking Climodien and contact your doctor immediately”.
Comparison
In women in their fifties who are not taking HRT, an average of 4 to 7 out of 1,000 are expected to have a blood clot in a vein over a 5-year period.
In women in their fifties who are taking estrogen-progestogen HRT, there will be 9 to 12 cases per 1,000 users (i.e., 5 additional cases) over a 5-year period.
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
Women over 60 years of age using estrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.
Stroke
The risk of stroke is approximately 1.5 times higher in users of HRT compared to non-users. The number of additional stroke cases due to HRT use increases with age.
Comparison
In women in their fifties not taking HRT, an average of 8 out of 1,000 are expected to have a stroke over a 5-year period. For women in their fifties taking HRT, there will be 11 cases per 1,000 users over a 5-year period (i.e., 3 additional cases).
Other diseases
HRT does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start HRT after age 65. Seek advice from your doctor.
Other medicines and Climodien
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, herbal remedies, or other natural products.
Your doctor will advise you accordingly.
Some medicines may interfere with the effect of Climodien. This may lead to irregular bleeding. This applies to the following medicines:
- Medicines for epilepsy (such as barbiturates, phenytoin, primidone, carbamazepine, and possibly oxcarbazepine, topiramate, and felbamate).
- Medicines for tuberculosis (such as rifampicin and rifabutin).
- Medicines for HIV infection and hepatitis C virus infection (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, ritonavir, and nelfinavir).
- Herbal preparations containing St. John’s wort (Hypericum perforatum).
- Medicines for the treatment of fungal infections (such as griseofulvin, fluconazole, itraconazol, ketoconazole, and voriconazole).
- Medicines for the treatment of bacterial infections (such as clarithromycin and erythromycin).
- Medicines for the treatment of certain heart conditions, high blood pressure (such as verapamil and diltiazem).
- Grapefruit juice.
HRT may affect the function of other medicines:
- A medicine for epilepsy (lamotrigine), as it could increase the frequency of seizures.
- Medicines for hepatitis C virus (HCV) (e.g., HCV combination regimens ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause elevations in blood liver function tests (increase in liver enzyme ALT) in women using COCs containing ethinylestradiol. Climodien contains estradiol instead of ethinylestradiol. It is unknown whether an increase in liver enzyme ALT may occur when Climodien is used with these HCV combination regimens.
Laboratory tests
If you need a blood test, inform your doctor or laboratory staff that you are taking Climodien, as this medicine may affect the results of certain tests.
Pregnancy and breastfeeding
Climodien is intended for use only in postmenopausal women. If pregnancy occurs, you must stop treatment with Climodien immediately and consult your doctor.
Driving and using machines
No effects on the ability to drive or use machines have been observed in users of Climodien.
Climodien contains sucrose, lactose, and glucose
Climodien contains sucrose, lactose, and glucose (types of sugars). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Climodien
Your doctor will aim to prescribe the lowest dose necessary to treat your symptoms for the shortest time needed. Please consult your doctor if you think this dose is too strong or not strong enough.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure. Your doctor will decide how long you should take Climodien.
The recommended dose is one tablet daily, preferably at the same time each day. Swallow the tablet whole with a glass of water. You may take Climodien with or without food. Start the next calendar pack the day after finishing the current one.
Do not take a break between packs.
If you have been taking other HRT medicines: continue until you have finished the current pack and taken all the tablets for that month. Take your first Climodien tablet the following day. Do not take a break between the old tablets and Climodien tablets.
If you have been using an HRT treatment with a weekly break: start the next day after the treatment-free period.
If this is your first HRT treatment: you may start your Climodien tablets at any time.
If you take more Climodien than you should
An overdose may cause nausea and vomiting and irregular bleeding. Specific treatment is not usually required, but you should consult your doctor if you are concerned.
If you have taken more Climodien than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (Tel: 91 562 04 20), stating the medicine and amount taken. It is recommended to bring the package and leaflet to the healthcare professional.
If you forget to take Climodien
If you forget to take a tablet at your usual time and less than 24 hours have passed, take it as soon as possible. Then take the next tablet at your usual time.
If more than 24 hours have passed, leave the missed tablet in the pack. Continue taking the remaining tablets at your usual time each day. Do not take a double dose to make up for a forgotten tablet.
If you miss taking your tablet for several days, breakthrough bleeding may occur.
If you stop taking Climodien
You may start to experience the usual symptoms of menopause again, which may include hot flushes, difficulty sleeping, nervousness, dizziness, or vaginal dryness. You will also begin to lose bone mass once you stop taking Climodien. Consult your doctor or pharmacist if you wish to stop taking Climodien tablets.
If you need to undergo surgery
If you are scheduled for surgery, inform your surgeon that you are taking Climodien. You may need to stop taking Climodien 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2, “Blood clots in a vein”). Ask your doctor when you can start taking Climodien again.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following diseases occur more frequently in women using HRT compared to women who do not take HRT:
- breast cancer
- abnormal growth or cancer of the inner lining of the womb (endometrial hyperplasia or cancer)
- ovarian cancer
- blood clots in the veins of the legs or lungs (venous thromboembolism)
- heart disease
- stroke
- possible memory loss if HRT is started after the age of 65.
For more information about these adverse effects, see section 2.
The following list of adverse effects has been associated with the use of Climodien:
Very common adverse effects:
- unexpected bleeding similar to menstruation (see also section 2 "Climodien and cancer/endometrial cancer")
- breast tension
- breast pain
During the first months of treatment with Climodien, unexpected bleeding similar to menstruation may occur. This is usually temporary and normally resolves with continued treatment. If it does not, consult your doctor.
Common adverse effects (may affect up to 1 in 10 people):
- headache, migraine, dizziness, fatigue, anxiety, depressive mood
- high blood pressure, worsening of high blood pressure
- dizziness, abdominal pain, diarrhoea, elevated gamma-GT (an enzyme)
- thickening of the inner lining of the uterus, genital inflammation, breast inflammation
- hot flushes
- changes in body weight, fungal infection
Uncommon adverse effects (may affect up to 1 in 100 people):
- insomnia, nervousness
- inflammation of veins, blood clot in veins (leg pain), painful veins
- constipation, abdominal bloating (gas), inflammation of the stomach
- increased sweating, hair loss, various skin disorders such as rash, eczema, and acne-like dermatitis
- changes in vaginal discharge, breast lumps (fibrocystic disease)
- allergic reactions
- fluid retention in the legs, changes in blood lipids, increased blood glucose, changes in sexual desire, muscle cramps, anaemia
Rare adverse effects (may affect up to 1 in 1,000 people):
- depression
- visual disturbances
- palpitations
- indigestion, changes in liver enzymes
- increase in size of fibroids
- increased appetite
The following adverse effects have been reported with other HRTs:
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gallbladder disease
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various skin disorders:
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skin discolouration, especially on the face or neck, known as “pregnancy mask” (chloasma)
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painful red nodules on the skin (erythema nodosum)
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skin rash with red spots resembling targets or sores (erythema multiforme)
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Climodien
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 is the last day of the month indicated.
Climodien does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Climodien
The active substances are estradiol valerate and dienogest. Each tablet contains 2.0 mg of estradiol valerate and 2.0 mg of dienogest.
The other components are monohydrate lactose, corn starch, pregelatinized corn starch, povidone K25 (E1201), and magnesium stearate (E470b). The components of the tablet coating are sucrose, liquid glucose, calcium carbonate (E170), povidone K25 (E1201), macrogol 35000, carnauba wax (E903), titanium dioxide (E171), and red iron oxide (E172).
Appearance of the product and contents of the package
Climodien tablets are round, film-coated, shiny, light pink tablets.
They are supplied in a blister pack containing 28 tablets, with the days of the week printed on the blister.
Cartons containing one or three blisters are available.
Marketing Authorization Holder
Bayer Hispania, S.L.
Avda. Baix Llobregat, 3 - 5
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturer
Bayer Weimar GmbH und Co. KG
Doebereinerstrasse 20
99427 Weimar
Germany
This medicinal product is authorized in the European Economic Area member states under the following names:
Spain, the Netherlands, Portugal: Climodien 2 mg/2 mg
Date of the most recent review of this leaflet:
September 2025
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es.