CINACALCET MACLEODS 60 mg FILM-COATED TABLETS

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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Cinacalcet Macleods and what is it used for
2. What you need to know before you take Cinacalcet Macleods
3. How to take Cinacalcet Macleods
4. Possible side effects
5. Storage of 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. It is used to treat disorders of the parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, which produce parathyroid hormone (PTH).

Cinacalcet is used in adults:

• to treat secondary hyperparathyroidism in adults with severe kidney disease who need 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:

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

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

2. What you need to know before you take Cinacalcet Macleods

Do nottake Cinacalcet Macleodsif you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).

Do not take cinacalcetif you have low levels of calcium in your blood. Your doctor will check your blood calcium levels.

Warnings and precautions

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

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

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

Cinacalcet reduces calcium levels. In adults and children treated with cinacalcet, life-threatening and fatal events associated with low calcium levels (hypocalcemia) have been reported.

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

Low calcium levels can affect your heart rhythm. Tell your doctor if you experience unusually strong or fast heartbeats, if you have problems with your heart rhythm, or if you take medicines that cause problems with your heart rhythm, while taking cinacalcet.

For more information, see section 4.

During treatment with cinacalcet, tell your doctor:

• if you start or stop smoking, as it may affect the effect of cinacalcet.

Children and adolescents

Children under 18 years with parathyroid cancer or primary hyperparathyroidism should not take cinacalcet.

If you are being treated for secondary hyperparathyroidism, your doctor should check your calcium levels before starting treatment with cinacalcet and during treatment with cinacalcet. You should tell 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 as directed by your doctor.

Other medicines and cinacalcet

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

You should not take cinacalcet with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines like the following may change the effect of cinacalcet:

• medicines used to treat skinand fungal infections(ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections(telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat HIVand AIDS(ritonavir);
• a medicine used to treat depression(fluvoxamine).

Cinacalcet may change the effect of some 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 drinks

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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Cinacalcet has not been studied in pregnant women. If you become pregnant, your doctor may decide to change your treatment, as cinacalcet may harm the unborn baby.

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

Driving and using machines

In patients taking cinacalcet, cases of dizziness and seizures have been reported. If you experience these effects, do not drive or use machines.

Cinacalcet containslactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Cinacalcet Macleods

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Your doctor will tell you how much cinacalcet to take.

Cinacalcet should be taken by mouth, with food or shortly after eating. The tablets should be swallowed whole and not chewed, crushed, or broken.

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

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

If the treatment is for secondary hyperparathyroidism

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

The usual starting dose of cinacalcet in children between 3 years and less than 18 years should not be higher than 0.20 mg/kg body weight per day.

If the treatment is for parathyroid cancer or primary hyperparathyroidism

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

If you take morecinacalcetthan you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist or call the Toxicology Information Service. Phone 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 takecinacalcet

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

If you have forgotten to take a dose of cinacalcet, you should take the next dose at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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) in your blood.
• If you notice swelling of the face, lips, mouth, tongue, or throat that may cause difficulty in swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• nausea and vomiting. These side effects are usually mild and temporary.

Common: may affect up to 1 in 10 people

• dizziness
• feeling of numbness or tingling (paresthesia)
• loss (anorexia) or decreased appetite
• muscle pain (myalgia)
• weakness (asthenia)
• rash
• decreased testosterone levels
• high levels of potassium in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (fits or convulsions)
• low blood pressure (hypotension)
• upper respiratory tract infections
• difficulty breathing (dyspnea)
• cough
• stomach upset (dyspepsia)
• diarrhea
• abdominal pain, upper abdominal pain

• constipation
• muscle spasms
• back pain
• low levels of calcium in the blood (hypocalcemia).

Not known: frequency cannot be estimated from the available data

• Hives (urticaria)

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

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side 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 which is stated on the carton and blister after “EXP:”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofCinacalcet 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.

• The other ingredients are:

Lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate

• The tablets are coated with:

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

Appearance and packaging

30 mg: Film-coated tablets are light green in color, oval, biconvex, engraved with ‘L83’ on one side and smooth on the other (approximate size 9.8 x 6.2 mm).

60 mg: Film-coated tablets are light green in color, oval, biconvex, engraved with ‘L84’ on one side and smooth on the other (approximate size 12.4 x 7.8 mm).

90 mg: Film-coated tablets are light green in color, oval, biconvex, engraved with ‘L85’ on one side and smooth on the other (approximate size 14.1 x 8.9 mm).

Cinacalcet Macleods is available in blisters.

Package sizes with blisters: 28, 30, and 84 tablets.

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

Not all 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 last revision of thisleaflet:January 2022

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