Progesterone 100 mg Capsules, soft

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Progesterone is and what it is used for
2. What you need to know before you take Progesterone
3. How to take Progesterone
4. Possible side effects
5. How to store Progesterone
6. Content of the pack and other information

• If you are allergic to progesterone, soya, peanut or any of the other ingredients of this medicine (listed in section 6);
• If you have ever had breast cancer, or if you are suspected of having it;
• If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it;
• If you have any unexplained vaginal bleeding;
• If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated;
• If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism);
• If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency);
• If you have or recently have had an illness caused by blood clots in the arteries, such as a heart attack, stroke or angina;
• If you have or have ever had a liver disease and your liver function tests have not returned to normal;
• If you have a rare (inherited) blood disorder called porphyria;
• If you have bleeding on the brain (cerebral haemorrhage);
• If you are breast-feeding (see 'Pregnancy and breast-feeding' section).

If any of the above conditions appear for the first time while taking Progesterone, stop taking it at once and consult your doctor immediately.

Before you start taking Progesterone, talk to your doctor if you have or have ever had any of the following conditions, as these may return or become worse during treatment with HRT. If so, you should see your doctor for more frequent check-ups:

• Abnormal tumours/growths (fibroids inside your womb);
• Growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia);
• Increased risk of developing blood clots;
• Increased risk of getting an oestrogen-sensitive cancer (such as having a close female relative who has had breast cancer);
• High blood pressure;
• Liver problems such as benign liver tumour;
• Diabetes;
• Gallstones;
• Migraine or severe headaches;
• A disease of the immune system that affects many organs of the body (Systemic Lupus Erythematosus [SLE]);
• Epilepsy;
• Asthma;
• A disease affecting the eardrum and hearing (otosclerosis);
• A very high level of fat in your blood (triglycerides);
• Fluid retention due to cardiac or kidney problems;
• Hereditary and acquired angioedema;
• You have ever had depression;
• Your skin is sensitive to light (photosensitivity).

Stop taking Progesterone and see a doctor immediately if you notice any of the following when taking HRT:

• Yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease;
• A large rise in your blood pressure (symptoms may include headache, tiredness, dizziness);
• Migraine-like headaches which happen for the first time;
• Sudden or gradual, partial or complete loss of vision;
• Forward displacement of the eye (proptosis) or double vision (diplopia);
• Swelling of the optic nerve (papilloedema);
• Eye diseases (retinal vascular lesions);
• If you become pregnant (see 'Pregnancy and breast-feeding' section);
• If you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, difficulty in breathing.

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer). The progestogen in Progesterone protects you from this extra risk.

Unexpected bleeding

You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking this medicine. However, if the irregular bleeding carries on for more than the first 6 months, starts after you have been taking Progesterone more than 6 months, or carries on after you have stopped taking Progesterone, see your doctor as soon as possible.

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (within 5 years at most) after stopping treatment.

In women aged 50 to 79 years who are not taking HRT, on average, 9 - 17 cases in 1000 will be diagnosed with breast cancer over a 5-year period. In comparison, women aged 50 to 79 years who are taking HRT, it is expected that there will be 13 - 23 cases in 1000 users, over 5 years.

Regularly check your breasts. See your doctor if you notice any changes such as dimpling of the skin, changes in the nipple, any lumps you can see or feel.

Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer only varies slightly. For example, in women aged 50 to 54 years who are not taking HRT, about 2 women in every 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, it is expected that there will be about 3 cases per 2000 users (i.e. 1 extra case).

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3 times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting, or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:

• You are unable to walk for a long time because of major surgery, injury, or illness (see also section 3, 'If you need to have surgery');
• You are seriously overweight (BMI > 30 kg/m²);
• You have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots;
• If any of your close relatives has ever had a blood clot in the leg, lung, or another organ;
• You have systemic lupus erythematosus (SLE);
• You have cancer.

For signs of a blood clot, see "Stop taking Progesterone and see a doctor immediately."

In women in their 50’s who are not taking HRT, on average, 4 - 7 cases in 1000 would be expected to get a blood clot in a vein over a 5-year period. In comparison, women in their 50’s who are taking HRT, it is expected that there will be 9 - 12 cases in 1000 users, over 5 years.

Heart disease and heart attacks

There is no evidence that HRT will prevent a heart attack.

Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of getting a stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

In women in their 50’s who are not taking HRT, on average, 8 cases in 1000 would be expected to have a stroke over a 5-year period. In comparison, women in their 50’s who are taking HRT, it is expected that there will be 11 cases in 1000 users, over 5 years.

HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65 years. Speak to your doctor for advice.

Progesterone is not for use in pre-pubescent children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription. This includes herbal medicines.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• blood thinners such as coumarins or phenindione
• ciclosporin or tacrolimus (used to reduce the immune response)
• tizanidine (muscle relaxant)
• bromocriptine (used to treat pituitary gland-related problems or Parkinson’s disease)
• selegiline (used to treat Parkinson’s disease)
• diazepam, chlordiazepoxide, alprazolam, oxazepam or lorazepam (used to treat anxiety or insomnia)
• medicines used to treat tuberculosis (such as rifampicin and rifabutin)
• antibiotics (such as ampicillin, amoxicillin and tetracyclines), used to treat certain infections
• phenytoin, phenobarbital, carbamazepine, eslicarbazepine, oxcarbazepine, primidone/rufinamide, perampanel or topiramate (used to treat epilepsy)
• herbal medicine products containing St John´s Wort
• darunavir, nelfinavir, fosamprenavir or lopinavir (used to treat viral infections)
• bosentan (used to treat lung problems)
• fluconazole, itraconazole, voriconazole, ketoconazole (used to treat fungal infections)
• atorvastatin or rosuvastatin (used to control cholesterol)
• aprepitant (used to prevent nausea and vomiting).

Tell your doctor or pharmacist:

• if you have recently been given an anaesthetic, such as bupivacaine
• if you have recently been tested for liver or hormone problems.

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

Do not take Progesterone with food.

• Do not take Progesterone if you are pregnant or might become pregnant.
• Progesterone is for use in post-menopausal women only. If you become pregnant, stop taking Progesterone and contact your doctor.
• Do not use this medicine if you are breast-feeding.

Note: Progesterone is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

You may feel sleepy or dizzy while taking Progesterone. If this happens, do not drive, use tools or operate machinery. Taking Progesterone at bedtime can reduce these effects.

If you are allergic to peanut or soya, do not use this medicine.

May very rarely cause a reaction in adults allergic to refined oils.

• The recommended dose is 200 mg (2 capsules) daily at bedtime for 12 days in the last half of each therapeutic cycle (beginning on Day 15 of the cycle and ending on Day 26).
• Alternatively, 100 mg (1 capsule) daily at bedtime can be given from Day 1 to Day 25 of each therapeutic cycle.

• Take this medicine orally at bedtime.
• Swallow the capsule whole with a glass of water. Do not take this medicine with food.
• Take your oestrogen HRT at the same time as Progesterone. Continue to take your oestrogen HRT every day.

• You will usually have a few days withdrawal bleeding (like a period) after treatment.
• If you have any problems with the withdrawal bleed, your doctor may change the way that you take Progesterone. This will help to reduce the amount of withdrawal bleeding.

If you are going to have surgery, tell the surgeon that you are taking HRT. You may need to stop taking HRT about 4 to 6 weeks before the operation to reduce the risk of a blood clot. Ask your doctor when you can start taking HRT again.

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.. Symptoms of an overdose include: feeling drowsy, dizzy, sleepy, or tired.

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

It is important that you keep taking Progesterone for as long as your doctor has told you to.

• Allergic reaction: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis)

The following are reported more often in women using HRT compared to women not using HRT:

• Breast cancer
• Abnormal growth or cancer of the 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 over the age of 65 years.

Other side effects

Common side effects (may affect up to 1 in 10 people)

• Weight changes
• Insomnia (difficulty falling and staying asleep, poor quality of sleep)
• Feeling tired or dizzy
• Headaches
• Abdominal swelling or pain
• Feeling sick (nausea)
• Itching
• Irregular or intermenstrual bleeding, vaginal bleeding, missing or absent periods
• Breast pain or tenderness
• Feeling generally unwell.

Uncommon side effects (may affect up to 1 in 100 people)

• Formation of blood clots in the blood vessels (thromboembolic disorders)
• Fluid retention, swelling
• Feeling agitated, anxious or nervous
• Lack of interest or energy
• Depression, mood swings
• Disorientation, memory loss
• Migraine
• Sensations like numbness, tingling, pins and needles, ringing or buzzing in the ears, spinning sensation
• Speech disorder
• Fainting, weakness
• Changes in your vision
• Palpitations or rapid heartbeat
• Hot flush, excessive sweating
• Low blood pressure
• Difficulty breathing
• Being sick (vomiting)
• Diarrhoea
• Constipation
• Non-severe and reversible liver disorders, yellowing of the skin or the whites of your eyes (jaundice)
• Hair loss or excessive hair (where there is usually very little or no hair)
• Reddening of the skin, itchy skin or rash, acne
• Joint, back or muscle pain, muscle spasms
• Abnormal menstrual cycle
• Breast discomfort, or tenderness, chest discomfort or pain
• Irregular thickening of the uterine lining (endometrial hyperplasia)
• Vaginal discharge, burning pain or discomfort in the vulva.

Rare side effects (may affect up to 1 in 1,000 people)

• Change in glucose tolerance
• Change in libido
• Eye irritation
• Loss of appetite
• Painful urination.

Very rare side effects (may affect up to 1 in 10,000 people)

• Skin discoloration (known as “pregnancy patches”).

Not known (frequency cannot be estimated from the available data)

• Urinary tract infection
• An inflammation of the vagina that can result in discharge, itching and pain (vaginitis)
• Taste disturbance
• Period pains
• Unexpected vaginal bleeding, spotting or blood-streaked discharge
• Fever.

The following side effect has been reported with other HRTs:

• Gall bladder disease.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• Each capsule contains 100 mg micronised progesterone.
• The other ingredients are: capsule contents: sunflower oil (refined) and soybean lecithin (E322), capsule shell: gelatine (E441), glycerol (E422), titanium dioxide (E171), and purified water.

• Progesterone 100 mg are off-white opaque, round, soft, gelatine capsules.
• They are available in a blister pack of 30 capsules.

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