CUPRIPEN 50 mg TABLETS

Introduction

Leaflet: information for the user

Cupripen 50 mg tablets

penicillamine

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Cupripen and what is it used for
2. What you need to know before taking Cupripen
3. How to take Cupripen
4. Possible side effects

5 Conservation of Cupripen

1. Package contents and additional information

1. What is Cupripen and what is it used for

Cupripen contains the active ingredient penicillamine, a chelating agent that acts mainly 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 or older for the treatment of:

• Wilson's disease, a disease in which the body cannot eliminate copper properly
• In cases of heavy metal poisoning

A kidney problem called cystinuria

2. What you need to know before taking Cupripen

Do not take Cupripen

• if you are allergic to penicillamine or any of the other components of this medication (listed in section 6),
• if you are allergic to penicillins,
• if you have had any liver, kidney, or severe blood diseases while taking penicillamine,
• if you have a disease called lupus erythematosus,
• if you are taking medications with gold salts, antimalarials, cytotoxics, oxyphenbutazone, or phenylbutazone.

Do not take Cupripen if you have any of the above conditions. If you are unsure, talk to your doctor or pharmacist before taking Cupripen, as this medication may worsen these problems.

Warnings and precautions

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

• you are elderly
• you are going to have or have had surgery.
• you have glucose-6-phosphate dehydrogenase deficiency
• you have liver or kidney problems
• if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication (see "Pregnancy, breastfeeding, and fertility").

Before starting treatment, tell your doctor or pharmacist if you have any of the conditions mentioned above. Your doctor will want to monitor the effect of the medication on you.

Special precautions for treatment with Cupripen:

Penicillamine may cause severe birth defects. You should avoid becoming pregnant while using Cupripen and for at least six months and five days after finishing treatment. See also the section "Pregnancy, breastfeeding, and fertility".

Recommended follow-up tests and safety measures:

Even when Cupripen is administered at low doses, severe side effects can occur. To detect them in time, it is necessary for your doctor to perform blood tests and check-ups.

Before starting treatment with Cupripen:

You will have blood and urine tests. If you have any liver or kidney disease, you will have tests to check liver and kidney function.

During treatment:

You will have the following tests, at least once a week for the first two months of treatment and then every month:

• blood tests
• urine tests

Maintain the frequency of doses indicated by your doctor to avoid the appearance of poor tolerance symptoms.

In prolonged treatments, your doctor may prescribe pyridoxine (Vitamin B6).

Other medications and Cupripen

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

If you are taking other medications, penicillamine may affect their mechanism of action or cause side effects. Therefore, it may be necessary to change the dose of the medication or suspend treatment in conjunction. If you take any of the following medications, consult your doctor or pharmacist before taking Cupripen:

• Aluminum or magnesium salts (medications used to treat heartburn)
• Digoxin (a medication used to treat heart conditions)
• Indomethacin (a medication used to treat pain)
• Isoniazid (a medication used to treat tuberculosis)
• Levodopa (a medication used to treat Parkinson's disease)
• Iron salts (medications used to treat low iron levels or anemia)
• Gold salts (a medication used to treat rheumatism)
• Phenylbutazone or oxyphenbutazone (medications used to treat pain and inflammation)
• Antimalarials (medications used to treat malaria)
• Cytotoxics (medications used to treat cancer)

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

Taking Cupripen with food and drinks

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 medication.

Pregnancy

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

Breastfeeding

It is not known whether Cupripen passes into breast milk. For this reason, its administration is not recommended during the breastfeeding period. Your doctor will decide if you can take Cupripen during this time.

Male fertility

Penicillamine may be genotoxic, which means it can cause genetic mutations. Therefore, you should avoid fathering a child or donating sperm 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 use tools or machines.

3. How to take Cupripen

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Method of administration

Cupripen is for oral use.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Dose

Your doctor will establish the appropriate dose for you and make the necessary adjustments, as the dosage should be individualized.

Wilson's disease

Adults

Your doctor will indicate how many tablets you should take per day. The usual dose is 1500 to 2000 mg per day. Once you feel better, your doctor may reduce the dose to 750 to 1000 mg per day. It is not recommended to take doses of 2000 mg per day for more than 12 months.

Use in elderly patients

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

Use in adolescents (12 to <18 years old)< em>

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

Use in children (5 to <12 years old)< em>

Your doctor will indicate 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 kilogram of weight, divided into two or three doses taken 1 hour before meals.

Patients with renal impairment

In patients with renal impairment, special precautions should be taken to control side effects.

Heavy metal poisoning

Adults (including elderly patients)

Your doctor will indicate how many tablets you should take per day. The dose is 1000 to 1500 mg per day until your doctor indicates that the amount of heavy metals in your urine is normal. If treatment is prolonged, the dose should not exceed 40 mg per day per kilogram of weight.

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

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

Cystinuria

The dose should be adjusted individually 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 before bedtime; in this case, you should drink at least 3 liters of fluid per day.

Use in elderly patients

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

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

The dose will depend on the child's weight. The usual dose is 20 to 30 mg per day per kilogram of weight in two or three divided doses taken 1 hour before meals. Your doctor may change the dose based on the results of the child's urine analysis.

Patients with renal impairment

In patients with renal impairment at the start of treatment, lower initial doses 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 you should, consult your doctor immediately.

If you forget to take Cupripen

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

If you stop treatment with Cupripen

Do not stop or change treatment without discussing it with your doctor, even if you feel better. If you have forgotten to take several doses, consult your doctor to indicate the dosage schedule to follow until you reach your maintenance dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The frequency and severity of side effects will depend on the dose and frequency of administration. It is essential that your doctor performs periodic checks, as severe side effects can occur even with the lowest doses. Your doctor will perform tests to monitor abnormalities that may occur in the blood and changes in the kidneys and liver.

Frequent (may affect up to 1 in 10 people)

• nausea, loss of taste, bad taste, loss of appetite, and vomiting.
• skin rashes
• redness of the skin (erythema)
• itching
• proteins in your urine (detected by a urine test)

Uncommon (may affect up to 1 in 100 people)

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

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

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

Unknown (cannot be estimated from available data)

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

Reporting side effects

If you experience any side effects, consult your doctor, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Cupripen

Keep this medication out of sight and reach of children.

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Cupripen 50 mg tablets:

• The active ingredient is penicillamine. Each Cupripen tablet contains 50 mg of penicillamine.
• The other ingredients are: Calcium phosphate dibasic, Corn starch, Magnesium stearate.

Appearance of the product and package contents

Cupripen 50 mg tablets:

Round, flat tablets with a central score line, white in color.

Available in a package 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 last revision of this leaflet:10/2023.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)