Cinacalcet Macleods 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cinacalcet Macleods 30 mg film-coated tablets EFG

Cinacalcet Macleods 60 mg film-coated tablets EFG

Cinacalcet Macleods 90 mg film-coated tablets EFG

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, ask your doctor, pharmacist or nurse.

• 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 may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Cinacalcet Macleods and what is it used for?

Cinacalcet works by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in your body, and is used to treat disorders of certain organs called parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid, which produce parathyroid hormone (PTH).

Cinacalcet is used in adults:

• to treat secondary hyperparathyroidism in adults with severe kidney disease who require dialysis to remove waste products from their blood.
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with parathyroid cancer.
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with primary hyperparathyroidism when removal of the parathyroid glands is not possible.

Cinacalcet is used in children between 3 years and less than 18 years of age:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from their blood, and whose condition is not controlled with other treatments.

In both primary and secondary hyperparathyroidism, the parathyroid glands produce too much PTH. The term "primary" means that hyperparathyroidism is not caused by another disease, while "secondary" means that hyperparathyroidism is caused by another condition, such as kidney disease. Both primary and secondary hyperparathyroidism can lead to loss of calcium from the bones, which may result in bone pain and fractures, problems in blood vessels and heart vessels, kidney stones, mental illness, and coma.

2. What you need to know before taking Cinacalcet Macleods

Do not take Cinacalcet Macleods if you are allergic to cinacalcet or to any of the other ingredients of this medicine (listed in section 6).

Do not take cinacalcet if you have low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take cinacalcet.

Before starting cinacalcet, inform your doctor if you have or have ever had:

• seizures (fits or convulsions). The risk of having seizures is higher in people who have already experienced them;
• liver problems;
• heart failure.

Cinacalcet lowers calcium levels. Life-threatening events and fatal outcomes associated with low calcium levels (hypocalcemia) have been reported in adults and children treated with cinacalcet.

Inform your doctor if you experience any of the following symptoms, which may indicate low calcium levels: muscle spasms, twitching, or cramps, or numbness or tingling in your fingers, toes, or around the mouth, or seizures, confusion, or loss of consciousness while taking cinacalcet.

Low calcium levels may affect your heart rhythm. Inform your doctor if you experience unusually strong or rapid heartbeat, have heart rhythm problems, or are taking medications that may cause heart rhythm disturbances while taking cinacalcet.

For additional information, see section 4.

During treatment with cinacalcet, inform your doctor:

• if you start or stop smoking, as this may alter the effect of cinacalcet.

Children and adolescents

Children under 18 years of age with parathyroid cancer or primary hyperparathyroidism must not take cinacalcet.

If you are being treated for secondary hyperparathyroidism, your doctor must monitor your calcium levels before starting and during treatment with cinacalcet. You must inform your doctor if you experience any of the symptoms related to low calcium levels described above.

It is important that you take your dose of cinacalcet exactly as prescribed by your doctor.

Other medicines and cinacalcet

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, particularly etelcalcetide or any other medicine that lowers calcium levels in your blood.

You must not receive cinacalcet together with etelcalcetide.

Inform your doctor if you are taking any of the following medicines.

The following medicines may alter the action of cinacalcet:

• medicines used to treat skin and fungal infections (ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat human immunodeficiency virus (HIV) infection and AIDS (ritonavir);
• a medicine used to treat depression (fluvoxamine).

Cinacalcet may alter the action of certain medicines, such as:

• medicines used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine);
• a medicine used to relieve cough (dextromethorphan);
• medicines used to treat heart rhythm disorders (flecainide and propafenone);
• a medicine used to treat high blood pressure (metoprolol).

Taking cinacalcet with food and drink

Cinacalcet should be taken with food or shortly after eating.

Pregnancy, breastfeeding, and fertility

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

Cinacalcet has not been studied in pregnant women. During pregnancy, your doctor may decide to change your treatment, as cinacalcet may be harmful to the unborn baby.

It is not known whether cinacalcet passes into breast milk. Your doctor will advise you whether to stop breastfeeding or stop treatment with cinacalcet.

Driving and using machines

Dizziness and seizures have been reported in patients taking cinacalcet. If you experience these effects, do not drive or operate machinery.

Cinacalcet contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Cinacalcet Macleods

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how much cinacalcet you should take.

Cinacalcet should be taken orally, with food or shortly after eating. The tablets must be swallowed whole and must not be chewed, crushed, or split.

Cinacalcet is also available as granules in capsules for opening. Children who require doses lower than 30 mg or who cannot swallow tablets should receive cinacalcet granules.

Your doctor will perform regular blood tests during treatment to monitor your progress and, if necessary, adjust the dose you receive.

If treatment is for secondary hyperparathyroidism

The usual starting dose of cinacalcet in adults is 30 mg (one tablet) once daily.

The usual starting dose of cinacalcet in children aged 3 years to less than 18 years should not exceed 0.20 mg/kg body weight per day.

If treatment is for parathyroid cancer or primary hyperparathyroidism

The usual starting dose of cinacalcet in adults is 30 mg (one tablet) twice daily.

If you take more cinacalcet than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount used. Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps, and seizures.

If you forget to take cinacalcet

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

If you forget to take a dose of cinacalcet, take the next dose at your usual time.

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

4. Possible adverse effects

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

Tell your doctor immediately:

• If you notice numbness or tingling around the mouth, muscle pain or cramps, and seizures. These may be symptoms of low calcium levels (hypocalcemia).
• If you notice swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• Nausea and vomiting. These adverse effects are usually mild and transient.

Common: may affect up to 1 in 10 people

• Dizziness
• Sensation of numbness or tingling (paresthesia)
• Loss (anorexia) or reduced appetite
• Muscle pain (myalgia)
• Weakness (asthenia)
• Skin rash
• Decreased testosterone levels
• High blood potassium levels (hyperkalemia)
• Allergic reactions (hypersensitivity)
• Headache
• Seizures (fits or attacks)
• Low blood pressure (hypotension)
• Upper respiratory tract infection
• Difficulty breathing (dyspnea)
• Cough
• Stomach discomfort (dyspepsia)
• Diarrhea
• Abdominal pain, upper abdominal pain
• Constipation
• Muscle spasms
• Back pain
• Low blood calcium levels (hypocalcemia)

Not known: frequency cannot be estimated from available data

• Hives (urticaria)
• Swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema)
• Unusually fast or strong heartbeat, which may be associated with low calcium levels in the blood (prolonged QT and secondary ventricular arrhythmia due to hypocalcemia)

In a small number of patients with heart failure, their condition and/or low blood pressure (hypotension) worsened after taking cinacalcet.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinacalcet Macleods

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

Do not use this medicine after the expiry date stated on the carton and blister after “EXP:”. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to 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 Cinacalcet Macleods

The active substance is cinacalcet.

30 mg: Each tablet contains cinacalcet hydrochloride equivalent to 30 mg of cinacalcet.

60 mg: Each tablet contains cinacalcet hydrochloride equivalent to 60 mg of cinacalcet.

90 mg: Each tablet contains cinacalcet hydrochloride equivalent to 90 mg of cinacalcet.

• Other components are:

Monohydrate lactose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate.

• The tablets are film-coated with:

Hypromellose, monohydrate lactose, triacetin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).

Appearance of the product and contents of the pack

30 mg: Light green, oval, biconvex film-coated tablets, engraved with ‘L83’ on one side and plain on the other (Approximate size 9.8 x 6.2 mm).

60 mg: Light green, oval, biconvex film-coated tablets, engraved with ‘L84’ on one side and plain on the other (Approximate size 12.4 x 7.8 mm).

90 mg: Light green, oval, biconvex film-coated tablets, engraved with ‘L85’ on one side and plain on the other (Approximate size 14.1 x 8.9 mm).

Cinacalcet Macleods is available in blister packs.

Blister pack sizes: 28, 30 and 84 tablets.

Unit dose blister packs of 28, 30 and 84 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, 62-020

Swarzedz, Poland

Date of the latest revision of this leaflet: January 2022

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