Leaflet: information for the user

Cupripen250 mg hard capsules

penicilamine

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Cupripen and what it is used for

2.What you need to know before starting to take Cupripen

3.How to take Cupripen

4.Possible side effects

5Storage of Cupripen

6.Contents of the pack and additional information

Cupripen contains the active ingredient penicilamine, a chelating agent that primarily acts by binding to certain metals in the body, including copper and lead, to help reduce the amounts of metals absorbed by the body. Penicilamine has the ability to form a soluble complex with cysteine.

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

• Wilson's disease, a condition in which the body is unable to properly eliminate copper
• Heavy metal poisoning

A kidney problem called cystinuria

Do not take Cupripen

• if you are allergic to penicillamineor to any of the other components of this medication (listed in section 6),
• if you are allergic to penicillins,
• if you have suffered from 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, oxifenbutazone, or phenylbutazone.

Do not take Cupripen if you have any of the above conditions. If you are unsure, speak with 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 to be or have been surgically operated on.
• 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 intend to become pregnant, consult your doctor or pharmacist before using this medication (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 want to monitor the effect of the medication on you.

Special precautions for Cupripen treatment:

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

Recommended follow-up tests and safety measures:

Even when Cupripen is administered at low doses, severe adverse effects can occur. To detect them in time, your doctor will need to perform blood tests and checks.

Before starting treatment with Cupripen:

You will have blood tests 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 as indicated by your doctor to avoid the appearance of symptoms of poor tolerance.

Your doctor may prescribe pyridoxine (Vitamin B6) for prolonged treatments.

Other medications and Cupripen

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

Penicillamine may affect the mechanism of action of other medications or cause side effects. Therefore, it may be necessary to change the dose of the medication or discontinue concurrent treatment. If you are taking 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 diseases)
• 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 oxifenbutazone (medications used to treat pain and inflammation)
• Antimalarials (medications used to treatmalaria)
• Cytotoxics (medications used to treat cancer)

If you have any doubts about 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.

Capsules should be swallowed whole with water.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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 this time.

Breastfeeding

The effects of Cupripen on breast milk are unknown. Therefore, it is not recommended to administer Cupripen during breastfeeding. Your doctor will decide if you can take Cupripen during this time.

Male fertility

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

Driving and operating machines

Cupripen is unlikely to affect your ability to drive or use tools or machines.

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

Administration Form

Cupripen is for oral use.

The capsules must be swallowed whole, with a glass of waterwith an empty stomach, at least 1 hour before or 2 hours after meals.

Dose

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

Wilson's Disease

Adults

Your doctor will indicate how many capsules you should take per day. The usual dose is 6 to 8 capsules per day. Once you feel better, your doctor may reduce the dose to 3 to 4 capsules per day. It is not recommended to take 8 capsules per day for more than 12 months.

Use in elderly people

Your doctor will indicate how many capsules 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)

Your doctor will indicate how many capsules you should take per day. The usual dose is 3 to 4 capsules per day.

Use in children (5 to <12)

Your doctor will indicate how many capsules 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.

Patients with renal insufficiency

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

Heavy Metal Poisoning

Adults (including elderly patients)

Your doctor will indicate how many capsules you should take per day. The dose is 4 to 6 capsules 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)

Your doctor will indicate how many capsules 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 can be administered up to a maximum dose of 1,050 mg of penicillamine per day per kilogram of weight.

Cystinuria

The dose should be adjusted individually, taking as parameters the amount of cystine excreted in urine.

Adults

If you are taking Cupripen to dissolve cystine stones, the dose is 4 to 12 capsules per day, divided into several doses. If you are taking Cupripen to prevent the formation of cystine stones, the dose will be 2 to 4 capsules per day before bedtime, in this case you should take a minimum of 3 liters of liquids per day.

Use in elderly people

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

Use in children and adolescents (5 to <18)

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

Patients with renal insufficiency

In patients with renal impairment 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 you should, consult your doctor immediately.

If you forget to take Cupripen

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Cupripen

Do not stop or change treatment without telling your doctor, even if you feel better. If you have forgotten to take several doses, consult your doctor to indicate the dosing 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 Toxicological Information Service, phone: 91 562 04 20.

Like all medicines, this medicine may 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 regular check-ups, as severe side effects can occur even with low doses. Your doctor will perform tests to monitor abnormalities in the blood, kidneys, and liver.

Frequent (may affect up to 1 in 10 people)

• nausea, loss of taste, bad taste, loss of appetite, and vomiting.
• skin eruptions
• skin redness (erythema)
• itching
• protein in your urine (detected by a urine analysis)

Infrequent (may affect up to 1 in 100 people)

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

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

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

Unknown (cannot be estimated from available data)

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

Reporting side effects

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

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from moisture.

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

Medications should not be disposed of through drains or trash. Dispose of the packaging and unused medications at the SIGRE drop-off point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Cupripen 250 mg hard capsules:

• The active ingredient is penicillamine. Each hard capsule of Cupripen contains 250 mg of penicillamine.
• The other components are:

Contents of the capsules:Magnesium stearate;Capsule coating:Gelatin, Titanium dioxide (E171), Quinoline yellow (E104).

Appearance of the product and contents of the packaging

Cupripen 250 mg hard capsules:

Cupripen are hard gelatin oval-shaped capsules, white and yellow in color.

They are presented in a package containing 30 capsules.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Rubió, S. A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal – Barcelona

Spain

Last review date of this leaflet:10/2023.

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