Cupripen 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cupripen 50 mg tablets

penicillamine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Cupripen is and what it is used for

Cupripen contains the active substance penicillamine, a chelating agent that works primarily by binding to certain metals in your body, including copper and lead, to help reduce the amounts of metals absorbed by your body. Penicillamine has the ability to form a soluble complex with cysteine.

Cupripen is indicated in adults, adolescents, and children aged 5 years and older for the treatment of:

• Wilson's disease, a condition in which the body cannot properly eliminate copper
• Heavy metal poisoning

A kidney condition called cystinuria

2. What you need to know before taking Cupripen

Do not take Cupripen

• if you are allergic to penicillamine or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to penicillins,
• if you have previously experienced liver disease, kidney disease, or serious blood disorders while taking penicillamine,
• if you have a condition called systemic lupus erythematosus,
• if you are taking medications containing gold salts, antimalarials, cytotoxic agents, oxphenbutazone, or phenylbutazone.

Do not take Cupripen if you have any of the conditions listed above. If you are unsure, speak with your doctor or pharmacist before taking Cupripen, as this medicine may worsen these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Cupripen if:

• you are elderly,
• you are scheduled for or have recently undergone surgery,
• you have glucose-6-phosphate dehydrogenase deficiency,
• you have liver or kidney problems,
• you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant; consult your doctor or pharmacist before using this medicine (see section “Pregnancy, breastfeeding, and fertility”).

Before starting treatment, inform your doctor or pharmacist if you have any of the conditions mentioned above. Your doctor will need to monitor how the medicine affects you.

Special precautionary measures for treatment with Cupripen:

Penicillamine may cause severe birth defects. You must avoid becoming pregnant while taking Cupripen and for at least six months and five days after stopping treatment. See also section “Pregnancy, breastfeeding, and fertility”.

Recommended follow-up tests and safety measures:

Even when administered at low doses, Cupripen may cause serious adverse effects. To detect them early, your doctor must perform regular blood and urine tests.

Before starting treatment with Cupripen:

You will have blood and urine tests. If you have liver or kidney disease, additional tests will be performed to assess liver and kidney function.

During treatment:

The following tests will be performed at least once a week during the first two months of treatment, and then once a month:

• blood tests,
• urine tests.

Maintain the dosing schedule prescribed by your doctor to avoid symptoms of poor tolerance.

During prolonged treatment, your doctor may prescribe pyridoxine (Vitamin B6).

Other medicines and Cupripen

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

Penicillamine may interfere with the action of other medicines or cause side effects. Therefore, it may be necessary to adjust the dose or discontinue one of the treatments. If you are taking any of the following medicines, consult your doctor or pharmacist before taking Cupripen:

• Aluminum or magnesium salts (medicines used to treat heartburn),
• Digoxin (a medicine used to treat heart conditions),
• Indomethacin (a medicine used to treat pain),
• Isoniazid (a medicine used to treat tuberculosis),
• Levodopa (a medicine used to treat Parkinson’s disease),
• Iron salts (medicines used to treat low iron levels or anemia),
• Gold salts (a medicine used to treat rheumatism),
• Phenylbutazone or oxphenbutazone (medicines used to treat pain and inflammation),
• Antimalarials (medicines used to treat malaria),
• Cytotoxic agents (medicines used to treat cancer).

If you are unsure whether any of the medicines you are taking are included in the list above, ask your doctor or pharmacist before taking Cupripen.

Taking Cupripen with food and drink

Take preferably on an empty stomach, 1 hour before or 2 hours after meals, as food interferes with its absorption.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of Cupripen during pregnancy is not recommended. Inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide whether you can take Cupripen during this time.

Breastfeeding

It is not known whether Cupripen passes into breast milk. Therefore, its use is not recommended during breastfeeding. Your doctor will decide whether you can take Cupripen during this period.

Male fertility

Penicillamine may be genotoxic, meaning it may cause genetic mutations. Therefore, you should avoid fathering a child or donating semen while taking Cupripen and for at least three months and five days after stopping treatment.

Driving and using machines

Cupripen is unlikely to affect your ability to drive or operate machinery.

3. How to take Cupripen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Method of administration

Cupripen is for oral use.

The score line is intended only for dividing the tablet if you have difficulty swallowing it whole.

Dosage

Your doctor will determine the appropriate dose for you and make any adjustments considered necessary, as dosing must be individualized.

Wilson's disease

Adults

Your doctor will tell you how many tablets to take each day. The usual dose is 1500 to 2000 mg per day. Once your condition has improved, your doctor may reduce the dose to 750 to 1000 mg per day. Doses of 2000 mg per day are not recommended for longer than 12 months.

Use in elderly patients

Your doctor will tell you how many tablets to take and how often during the day. The dose will depend on your body weight. The usual dose is 20 mg of penicillamine per day per kg of body weight. Your doctor will adjust the dose to the minimum level necessary to control your disease.

Use in adolescents (12 to < 18 years)

Your doctor will tell you how many tablets to take each day. The usual dose is 750 to 1000 mg per day.

Use in children (5 to < 12 years)

Your doctor will tell you how many tablets the child should take and how often during the day. The dose will depend on the child's weight. The usual dose is 20 mg of penicillamine per day per kg of body weight, divided into two or three doses.

Patients with renal impairment

Special precautions should be taken in patients with renal abnormalities to monitor for adverse effects.

Heavy metal poisoning

Adults (including elderly patients)

Your doctor will tell you how many tablets to take each day. The dose is 1000 to 1500 mg per day until your doctor determines that the level of heavy metals in your urine is normal. If treatment is prolonged, the dose should not exceed 40 mg per day per kg of body weight.

Use in children and adolescents (5 to < 18 years)

Your doctor will tell you how many tablets to take each day. The dose will depend on the child's weight. The usual dose is 20 to 25 mg per day per kg of body weight. If necessary, a dose of up to 100 mg of penicillamine per day per kg of body weight may be administered, up to a maximum dose of 1050 mg of penicillamine per day per kg of body weight.

Cystinuria

The dose must be individually adjusted based on the amount of cystine excreted in the urine.

Adults

If you are taking Cupripen to dissolve cystine stones, the dose is 1000 to 3000 mg per day, divided into several doses. If you are taking Cupripen to prevent the formation of cystine stones, the dose will be 500 to 1000 mg per day taken before bedtime; in this case, you should drink a minimum of 3 liters of fluid per day.

Use in elderly patients

Your doctor will determine the appropriate dose for you, which should be the minimum required to maintain cystine levels below 200 mg per liter of urine.

Use in children and adolescents (5 to < 18 years)

The dose will depend on the child's weight. The usual dose is 20 to 30 mg per day per kg of body weight, given in two or three separate doses taken 1 hour before meals. Your doctor may adjust the dose depending on the child's urinary test results.

Patients with renal impairment

In patients with renal abnormalities at the start of treatment, initial doses lower than those recommended should be administered. Maintenance doses should be reviewed at least every 4 weeks.

If you take more Cupripen than you should

If you take more Cupripen than prescribed, consult your doctor immediately.

If you forget to take Cupripen

Do not take a double dose to make up for missed doses.

If you stop taking Cupripen

Do not stop or change your treatment without discussing it with your doctor, even if you feel better. If you have missed several doses, consult your doctor for advice on the dosing schedule to follow until your maintenance dose is reached.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The frequency and severity of adverse effects will depend on the dose and frequency of administration. It is important that your doctor carries out periodic monitoring, as serious adverse effects may occur even with the lowest doses. Your doctor will perform tests to monitor blood abnormalities and changes in the kidneys and liver.

Frequent (may affect up to 1 in 10 people)

• nausea, loss of taste, altered taste, loss of appetite, and vomiting
• skin rashes
• redness of the skin (erythema)
• itching
• protein in the urine (detected by a urine test)

Uncommon (may affect up to 1 in 100 people)

• ringing in the ears (tinnitus)
• loss of vision
• muscle weakness, joint pain (arthralgia)
• excessive excretion of protein in the urine (nephrotic syndrome)
• inflammatory kidney involvement (membranous glomerulonephritis)

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

• diarrhea
• decreased number of blood cells (anemia, leucopenia, thrombocytopenia)
• mouth ulcers
• hair loss
• inflammation of lung tissue (pneumonitis)
• bronchiolitis
• yellowish discoloration of the nails (yellow nail syndrome)
• inflammatory disease causing muscle weakness (polymyositis)
• breast enlargement

Not known (cannot be estimated from available data)

• pseudoxanthoma elasticum (a connective tissue disease)
• perforating elastosis (a skin disease)
• lupus erythematosus (an allergic condition causing joint pain, skin rashes, and fever)
• myasthenia gravis (a disease causing muscle weakness)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cupripen

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from moisture.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cupripen 50 mg tablets:

• The active substance is penicillamine. Each Cupripen tablet contains 50 mg of penicillamine.
• The other components are: dibasic calcium phosphate, corn starch, magnesium stearate.

Appearance of the product and contents of the pack

Cupripen 50 mg tablets:

White, round, flat tablets with a central groove.

Packaged in a container containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Rubió, S. A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal – Barcelona

Spain

Date of the most recent review of this leaflet: 10/2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)