Sapropterin Teva 100 mg soluble tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sapropterin Teva 100 mg dispersible tablets EFG

sapropterin dihydrochloride

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 effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Sapropterin Teva is and what it is used for

This medicine contains the active substance sapropterin, which is a synthetic copy of a substance naturally present in the body called tetrahydrobiopterin (BH4). BH4 is required in the body to convert an amino acid called phenylalanine into another amino acid called tyrosine.

Sapropterin Teva is used to treat hyperphenylalaninemia (HPA) or phenylketonuria (PKU) in patients of any age. HPA and PKU are caused by abnormally high levels of phenylalanine in the blood, which can be harmful. Sapropterin reduces these levels in some patients who respond to BH4 and may help increase the amount of phenylalanine that can be included in the diet.

This medicine is also used to treat an inherited disorder called BH4 deficiency in patients of any age, in which the body cannot produce sufficient amounts of BH4. Because BH4 levels are very low, the body cannot properly utilize phenylalanine, leading to increased levels of this amino acid and harmful effects. By replacing the BH4 that the body cannot produce, Sapropterin Teva reduces the harmful excess of phenylalanine in the blood and increases dietary phenylalanine tolerance.

2. What you need to know before starting to take Sapropterin Teva

Do not take Sapropterin Teva

If you are allergic to sapropterin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Sapropterin Teva, especially:

• if you are 65 years of age or older
• if you have kidney or liver problems
• if you are unwell. It is recommended to consult your doctor during illness, as
• blood phenylalanine levels may increase
• if you are predisposed to seizures

While receiving treatment with sapropterin, your doctor will perform blood tests to monitor your levels of phenylalanine and tyrosine, and will decide whether adjustments to your sapropterin dose or diet are needed.

You must continue your dietary treatment as recommended by your doctor. Do not change your diet without informing your doctor. Even when taking sapropterin, if your blood phenylalanine levels are not well controlled, you may experience serious neurological problems. Your doctor must continue to monitor your blood phenylalanine levels regularly during treatment with sapropterin, to ensure they are neither too high nor too low.

Other medicines and Sapropterin Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor if you are using:

• levodopa (used to treat Parkinson's disease)
• medicines for the treatment of cancer (e.g., methotrexate)
• medicines for the treatment of bacterial infections (e.g., trimethoprim)
• medicines that cause blood vessel dilation (e.g., glyceryl trinitrate [GTN], isosorbide dinitrate [ISDN], sodium nitroprusside [SNP], molsidomine, minoxidil).

Pregnancy and breastfeeding

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

If you are pregnant, your doctor will advise you on how to properly control your phenylalanine levels. If these levels are not strictly controlled before or during pregnancy, it may be harmful to you and your baby. Your doctor will monitor dietary restriction of phenylalanine intake before and during pregnancy.

If a strict diet does not sufficiently reduce the amount of phenylalanine in the blood, your doctor will consider whether you should take this medicine.

You must not use this medicine during breastfeeding.

Driving and using machines

Sapropterin Teva is not expected to affect your ability to drive or operate machinery.

Sapropterin Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Sapropterin Teva

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor again.

Dose for PKU

The recommended starting dose of Sapropterin Teva in patients with PKU is 10 mg per kg of body weight. Take Sapropterin Teva once daily with a meal to enhance absorption, at the same time each day, preferably in the morning. Your doctor may adjust the dose, usually between 5 and 20 mg per kg of body weight per day, depending on your condition.

Dose for BH4 deficiency

The recommended starting dose of Sapropterin Teva in patients with BH4 deficiency is 2 to 5 mg per kg of body weight. Take Sapropterin Teva with a meal to enhance absorption. Divide the total daily dose into 2 or 3 doses taken throughout the day. Your doctor may adjust the dose up to 20 mg per kg of body weight per day, depending on your condition.

The following table is an example of how to calculate the appropriate dose

Administration method

For patients with PKU, the total daily dose should be taken once daily and at the same time each day, preferably in the morning.

For patients with BH4 deficiency, the total daily dose should be divided into 2 or 3 doses taken throughout the day.

Use in all patients

Place the prescribed tablets into a glass or cup of water, exactly as described below, and stir until they dissolve.

The tablets may take a few minutes to dissolve. To speed up dissolution, you may crush the tablets. Small particles may be visible in the solution, but these will not affect the effectiveness of the medicine. Drink the dissolved Sapropterin Teva preparation with a meal within 15 to 20 minutes of preparation.

Do not ingest the desiccant capsule included in the bottle.

Use in patients with body weight above 20 kg

Place the tablets in a glass or cup (120 to 240 ml) of water and stir until they dissolve.

Use in children up to 20 kg body weight

The dose is based on body weight, which will change as the child grows. Your doctor will advise you:

• the number of Sapropterin Teva tablets required for a dose
• the amount of water needed to mix a dose of Sapropterin Teva
• the volume of solution to administer to the child for the prescribed dose

The child should drink the solution with a meal.

Administer the prescribed volume of solution to the child within 15 to 20 minutes after the tablets have dissolved. If you are unable to administer the dose to the child within 15 to 20 minutes after dissolving the tablets, you must prepare a fresh solution, as unused solution must not be used after 20 minutes.

Materials required to prepare and administer the dose of Sapropterin Teva to the child

• The number of Sapropterin Teva tablets required for a dose
• A dosing cup with graduations marked at 20, 40, 60, and 80 ml
• A glass or cup
• A clean spoon or stirring utensil
• An oral syringe (graduated in 1 ml increments; a 10 ml oral syringe for administering volumes ≤10 ml or a 20 ml oral syringe for administering volumes >10 ml)

Ask your doctor for the dosing cup to dissolve the tablets and the 10 ml or 20 ml oral syringe if you do not already have these materials.

Steps for preparing and administering the dose:

• Place the prescribed tablets into the dosing cup. Add the amount of water indicated by your doctor (e.g., your doctor may have instructed you to use 20 ml to dissolve one Sapropterin Teva tablet). Ensure the liquid volume aligns with the corresponding graduation mark on the dosing cup as specified by your doctor. Stir with a clean spoon or utensil until the tablets dissolve.
• If your doctor has instructed you to administer only part of the solution, insert the tip of the oral syringe into the dosing cup. Slowly pull back the plunger to withdraw the volume specified by your doctor.
• Transfer the solution to a glass or dosing cup by slowly pushing the plunger until all the solution previously drawn into the oral dosing syringe is dispensed (e.g., if your doctor instructed you to dissolve two Sapropterin Teva tablets in 40 ml of water and administer 30 ml to the child, you will need to use the 20 ml oral dosing syringe twice to withdraw and transfer 30 ml of solution (e.g., 20 ml + 10 ml) into a glass or dosing cup). Use a 10 ml oral syringe for volumes ≤10 ml or a 20 ml oral syringe for volumes >10 ml.
• If the infant is too young to drink from a glass or cup, you may administer the solution using the oral syringe. Withdraw the prescribed volume of prepared solution from the dosing cup and insert the tip of the oral syringe into the infant’s mouth. Direct the tip of the oral syringe toward one of the cheeks. Slowly push the plunger so that a small amount is released at a time, until the entire solution in the oral syringe has been administered.
• Discard any remaining solution. Remove the plunger from the barrel of the oral syringe. Wash both parts of the oral syringe and the dosing cup with warm water and allow them to air dry. Once the oral syringe is dry, reinsert the plunger into the barrel. Store the oral syringe and dosing cup for future use.

If you take more Sapropterin Teva than you should

If you take more Sapropterin Teva than prescribed, you may experience adverse effects such as headache and dizziness. If you take more than the prescribed amount, inform your doctor or pharmacist immediately.

If you suspect an overdose and experience any of these symptoms, notify your doctor immediately. You may also call the Toxicology Information Service at Tel. 91 562 0420.

If you forget to take Sapropterin Teva

Do not take a double dose to make up for a missed dose. Take the next dose at your usual scheduled time.

If you stop taking Sapropterin Teva

Do not stop treatment with Sapropterin Teva without first discussing it with your doctor, as blood phenylalanine levels may increase.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

A few cases of allergic reactions (such as skin rashes and severe reactions) have been reported. Their frequency is unknown (the frequency cannot be estimated from the available data).

If you develop swollen, red, intensely itchy areas (urticaria), runny nose, rapid or irregular pulse, swelling of the tongue or throat, sneezing, wheezing, severe breathing difficulty, or dizziness, you may be experiencing a severe allergic reaction to the medicine. If you have these symptoms, consult your doctor immediately.

Very common adverse effects (may affect more than 1 in 10 people):

Headache and runny nose.

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

Sore throat, nasal congestion or stuffiness, cough, diarrhoea, vomiting, stomach pain, blood phenylalanine levels too low, indigestion, and general discomfort (nausea) (see section 2: "Warnings and precautions").

Adverse effects frequency not known (cannot be estimated from the available data):

Gastritis (inflammation of the stomach lining), oesophagitis (inflammation of the oesophageal lining).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sapropterin Teva

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

Do not use this medicine after the expiry date stated on the label and on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 25°C. Keep in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Sapropterin Teva

• The active substance is sapropterin dihydrochloride. Each tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
• The other components are mannitol (E421), pregelatinized starch (from corn), crospovidone (E1202), riboflavin (E101), ascorbic acid (E300), stearic fumarate, and sodium.

Appearance of the product and contents of the container

Sapropterin Teva 100 mg dispersible tablets are round, white to light yellow tablets, approximately 9.5 mm in diameter, marked with “L71” on one side and “T” on the opposite side.

It is presented in high-density polyethylene (HDPE) bottles with a child-resistant safety closure. Each bottle contains 30 or 120 tablets. The bottles are sealed with an aluminum foil seal. Each bottle contains a small plastic tube with desiccant (silica gel).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Manufacturer

Teva Operations Poland Sp. Z.o.o

ul. Mogilska 80

31-546 Krakow

Poland

Date of the most recent review of this leaflet: March 2022

Other sources of information

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