Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - mycapssa

Document Subject

Generated Narrative: MedicinalProductDefinition mp8734938a1d7cc06ba1013b88ab4857e8

identifier: http://ema.europa.eu/identifier/EU/1/22/1690/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Mycapssa 20 mg gastro-resistant hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8734938a1d7cc06ba1013b88ab4857e8

identifier: http://ema.europa.eu/identifier/EU/1/22/1690/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - mycapssa

Attesters

What is in this leaflet

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

Mycapssa contains the active substance octreotide. Octreotide is a synthetic form of somatostatin, a natural substance that controls the release of human growth hormone. Octreotide works in the same way as somatostatin, but its action lasts longer so it does not need to be taken so often.

Mycapssa is used for maintenance treatment in adults with acromegaly, a condition wherein the body produces too much growth hormone. It is used in patients in whom medicines like somatostatin have already been shown to be of benefit.

Normally, growth hormone regulates the growth of tissues, organs and bones. In acromegaly, increased production of growth hormone (usually from a non-cancerous tumour in the pituitary gland) leads to enlargement of bones and certain tissues, and symptoms such as headache, excessive sweating, numbness in the hands and feet, tiredness and joint pain. Treatment with Mycapssa can help relieve the symptoms.

Do not take Mycapssa

• if you are allergic to octreotide or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions Talk to your doctor or pharmacist before taking Mycapssa or during treatment if you have:

• heart or blood circulation problems, since the medicine can affect the rate and regularity of your heartbeat.
• gallbladder problems. Octreotide can cause gallstones to form, and your doctor will recommend ultrasound scans to check for this, usually every 6 to 12 months while you are being treated with this medicine.
• diabetes, since Mycapssa may affect your blood sugar. Persistent increased blood sugar levels may occur during long-term use. Low blood sugar levels have also been reported. Therefore, your doctor may recommend monitoring blood sugar levels and treatment of diabetes. If you have type I diabetes and you are being treated with insulin, your doses may need to be reduced during treatment with Mycapssa.
• ever had lack of vitamin B12. If you have a history of lacking vitamin B12, your doctor may wish to check your vitamin B12 level periodically during treatment with Mycapssa since this medicine can decrease vitamin B12 levels in the blood.

Monitoring during treatment Tumours of the pituitary gland that produce excess growth hormone and lead to acromegaly sometimes expand, causing serious complications such as visual problems. It is essential that you are monitored for tumour growth while taking Mycapssa. If evidence of tumour expansion appears, your doctor may prescribe a different treatment.

Your doctor will regularly check your liver function during treatment and will also check your thyroid function when treatment with Mycapssa is prolonged.

Children and adolescents Mycapssa is not recommended in children and adolescents under 18 years because it is not known if it is safe or effective in this age group.

Other medicines and Mycapssa Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking the following medicines as they may change how Mycapssa works:

• medicines which control or reduce stomach acid
• metoclopramide: a medicine to treat nausea and vomiting
• loperamide: a medicine to treat diarrhoea

Also, tell your doctor if you are taking any of the following medicines, which may be affected when used with Mycapssa. If you take these medicines, your doctor may need to adjust the doses of these medicines:

• medicines called beta blockers, used to treat high blood pressure, heart disease or other illnesses
• medicines called calcium channel blockers, used to treat high blood pressure or heart diseases
• hydrochlorothiazide: a medicine to treat high blood pressure and tissue swelling caused by excess fluid
• quinidine: a medicine to treat irregular heart rhythm
• lisinopril: a medicine to treat high blood pressure and other heart and specific kidney diseases
• digoxin: a medicine to treat heart weakness and irregular heartbeat
• medicines to treat fluid and electrolyte balance
• insulin or other medicines to treat diabetes
• ciclosporin: a medicine to suppress transplant rejection, treat severe skin diseases, severe eye and joint inflammation
• bromocriptine: a medicine to treat Parkinson s and other diseases (e.g. pituitary tumours) and to aid weaning
• oral contraceptives, such as birth control pills: a medicine to prevent pregnancy or to treat intensive menstrual bleeding Mycapssa may reduce the effectiveness of oral hormonal contraceptives containing progestogens.

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.

Avoid taking Mycapssa during pregnancy and breast-feeding. This is a precaution, as there is limited information on the use of Mycapssa during pregnancy and breast-feeding.

Women who can get pregnant should use effective contraception during treatment with Mycapssa. Discuss appropriate methods with your doctor as Mycapssa may reduce the effectiveness of oral contraceptives containing progestogens. If you are using such contraceptives, you are therefore advised to use other non-hormonal methods of contraception or add a back-up method while taking Mycapssa.

Driving and using machines Mycapssa has no or negligible influence on the ability to drive and use machines. However, avoid driving or using machines if your ability to react is reduced due to side effects such as dizziness, weakness/fatigue or headache.

Mycapssa contains sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially sodium-free .

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

The recommended starting dose is 1 capsule twice daily.

The doctor will gradually increase the dose in steps of 1 capsule daily to adequately control your disease, up to a maximum recommended daily dose of 4 capsules. Your doctor will check your symptoms and the levels of a substance called insulin-like growth factor every 2 weeks or so after each increase, to check how your body is responding to the new dose and find the right dose for you.

Your doctor will check your symptoms less frequently once you are on a regular daily dose. During these checks your doctor will make sure that the medicine is still working well for you.

Method of use Always take this medicine as instructed by your doctor. Swallow the capsules whole with a glass of water, at least 1 hour before or 2 hours after eating any food. It is recommended to have a routine schedule for taking Mycapssa in relation to food every day (for example, take Mycapssa routinely at least 1 hour before breakfast and at least 2 hours after dinner).

How to remove a capsule from blister:
Press GENTLY on top or bottom of capsule.

DO NOT press the middle of the capsule. This could damage it. If a capsule is cracked or broken, throw it away (discard it) and remove another capsule.

If you take more Mycapssa than you should If you have accidentally taken more Mycapssa than you should, stop taking this medicine and tell your doctor straight away.

If you forget to take Mycapssa Do not take a double dose to make up for a forgotten dose. Administer one dose as soon as you remember, as long as it is taken at least 6 hours before the next scheduled dose. Otherwise, skip the missed dose and take your next dose at the usual time.

If you stop taking Mycapssa Do not stop taking this medicine without discussing with your doctor first. If you stop taking Mycapssa, your acromegaly symptoms may come back.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects can occur with the following frequencies: Very common (may affect more than 1 in 10 people)

• abdominal (belly) pain
• diarrhoea
• nausea
• increased blood sugar level
• headache
• constipation
• wind
• gallstones

Common (may affect up to 1 in 10 people)

• dizziness
• discomfort or bloating or swelling of your abdomen (belly)
• indigestion
• inflammation of stomach lining
• disease caused by reflux of stomach juices
• vomiting
• joint pain
• weakness, fatigue
• swelling of arms and/or legs
• increased levels of liver enzymes
• low blood sugar level
• discoloured stool, soft stool
• loss of appetite
• slow heartbeat
• difficulty breathing
• excess fat in stool
• acute inflammation of the gallbladder
• thickening of bile
• increased blood level of bilirubin, a waste product from breakdown of red blood cells
• itching, rash
• hair loss
• thyroid problems

Uncommon (may affect up to 1 in 100 people)

• inflammation of abnormal pouches in the wall of the large intestine

• inflammation of the stomach and bowel lining

• herpes (sores) of the mouth lining

• non-aggressive tumour of liver blood vessels

• reduced number of white blood cells

• decreased appetite

• diabetes mellitus

• dehydration

• high blood fat values of triglycerides

• restlessness

• anxiety

• depression, disorientation, altered mood, mood swings

• hallucination in hearing, visual hallucination

• sleeping difficulties

• pain, numbness and tingling in the wrist or hand

• disturbed attention

• taste disturbance

• reduced memory

• abnormal sensation such as reduced sense of touch, burning, prickling, tingling and itchiness

• feeling faint

• headache due to blocked sinuses

• drowsiness

• shaking

• increased flow of tears

• irregular heartbeat, fast heartbeat

• sudden skin reddening and feeling very hot

• low blood pressure

• disorder of the inner lining in the nose, throat irritation

• acute pancreas inflammation

• change of bowel habit

• dry mouth

• stool incontinence, increased stool volume

• frequent bowel movements

• stomach and bowel disorder, such as motility disorder

• bleeding haemorrhoids (piles)

• pain when swallowing

• a disorder called achalasia which can cause the lower gullet sphincter to remain closed, causing difficulty in swallowing

• parotid (jaw) gland enlargement

• feeling of incomplete bowel emptying

• bile duct obstruction

• yellowing of the skin, internal organs and/or whites of the eyes

• complaints after surgical removal of the gallbladder called post cholecystectomy syndrome

• gallbladder attack, gallbladder disorder

• fatty liver

• allergic skin inflammation

• increased sweating

• condition of excessive body hair

• pain, such as back pain, bone pain, flank pain, groin pain

• joint swelling

• muscle spasms

• discomfort or pain of muscles and skeleton

• pain in arms and legs

• soft tissue swelling

• feeling abnormal or unwell

• feeling of body temperature change

• tenderness

• thirst

• heart murmur

• increased or decreased weight

• increased blood levels of:

• creatine phosphokinase

• creatinine

• lactate dehydrogenase

• urea

• insulin-like growth factor

• lipase

• thyroxine

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

• heart disorder
• increased growth hormone levels in the blood
• low platelet counts, potentially leading to bruising or bleeding
• severe allergic reactions or other allergic reactions
• abnormal heart rhythms
• liver inflammation
• reduced bile flow
• jaundice
• nettle-rash

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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 carton and blister after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze.

Mycapssa can be kept out of refrigeration for up to 1 month, but may not be stored above 25 C, after which the medicine must be discarded.

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

What Mycapssa contains

• The active substance is octreotide. One capsule contains octreotide acetate equivalent to 20 mg octreotide.
• The other ingredients are povidone, sodium caprylate, magnesium chloride, polysorbate 80, glyceryl monocaprylate, glyceryl tricaprylate, gelatine, titanium dioxide (E171), methacrylic acid - ethyl acrylate copolymer (1:1), talc, triethyl citrate, silica, colloidal anhydrous, sodium hydrogen carbonate, sodium laurilsulfate (see section 2 Mycapssa contains sodium ).

What Mycapssa looks like and contents of the pack Mycapssa are white gastro-resistant hard capsules (gastro-resistant capsule). They are packed in plastic/aluminium blisters in a carton.

Pack size: 28 gastro-resistant hard capsules

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Amryt Pharmaceuticals DAC 45 Mespil Road Dublin 4 Ireland

Manufacturer Pharbil Pharma GmbH Reichenberger Strasse 33605 Bielefeld Germany

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: