Prospect: information for the patient

Cinacalcet Tillomed 30 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1. What is Cinacalcet Tillomed and for what it is used

2. What you need to know before starting to take Cinacalcet Tillomed

3. How to take Cinacalcet Tillomed

4. Possible adverse effects

5. Storage of Cinacalcet Tillomed

6. Contents of the package and additional information

Cinacalcet acts by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body, and is used to treat alterations of the parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, that 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 Tillomed is not indicated in children between 3 years and less than 18 years.

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, for example, kidney disease. Both primary and secondary hyperparathyroidism can cause loss of calcium from the bones, which can produce bone pain and fractures, problems in blood vessels and heart vessels, kidney stones, mental disease, and coma.

Do not take Cinacalcet Tillomed

• if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
• if you have low levels of calcium in your blood. Your doctor will monitor your calcium levels in the blood.

Warnings and precautions

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

Before starting to take cinacalcet, inform your doctor if you have ever suffered from:

• seizures(attacks or crises). The risk of seizures is higher in people who have had them before;
• liver problems;
• heart failure

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

Inform 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 of the hands, feet, or around the mouth, or seizures, confusion, or loss of consciousness while being treated with cinacalcet.

Low calcium levels can affect your heart rhythm. Inform your doctor if you experience abnormally strong or rapid heartbeats, if you have problems with your heart rhythm, or if you take medications that cause heart rhythm problems, while taking cinacalcet.

For additional information, see section 4.

During treatment with cinacalcet, inform your doctor:

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

Children and adolescents

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

Taking cinacalcet Tillomed with other medicines

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

You should not receive cinacalcet together with etelcalcetide.

Inform your doctor if you are taking the following medicines.

The following medicines may modify the action of cinacalcet:

• medicines used to treatskinand fungal infections (ketoconazole, itraconazole, and voriconazole);
• medicines used to treatbacterial infections(telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat infections caused by the human immunodeficiency virus (HIV) and AIDS (ritonavir);
• a medicine used to treatdepression(fluvoxamine).

Cinacalcet may modify the action of the following medicines:

• medicines used to treatdepression(amitriptyline, desipramine, nortriptyline, and clomipramine);
• a medicine used to relievecough(dextromethorphan);
• medicines used to treatheart rhythm disorders(flecainide and propafenone);
• a medicine used to treathigh blood pressure(metoprolol).

Taking Cinacalcet Tillomed with food and drinks

Cinacalcet should be taken with food or shortly after eating.

Pregnancy, breastfeeding, and fertility

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

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

It is not known whether cinacalcet passes into breast milk. Your doctor will tell you if you should stop breastfeeding or the treatment with cinacalcet.

Driving and operating machinery

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

Cinacalcet Tillomed contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how much cinacalcet to take.

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

Your doctor will make 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 initial dose of cinacalcet in adults is 30 mg (one tablet) once a day.

If treatment is for parathyroid cancer or primary hyperparathyroidism

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

If you take more Cinacalcet Tillomed than you should

If you have taken more cinacalcet than you should, contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps, and seizures.

If you forgot to take Cinacalcet Tillomed

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

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform 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 in the face, lips, mouth, tongue, or throat that may cause difficulty 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 decrease in appetite
• Muscle pain (myalgia)
• Weakness (asthenia)
• Skin rash
• Decreased levels of testosterone
• High levels of potassium in the blood (hyperkalemia)
• Allergic reactions (hypersensitivity)
• Headache
• Seizures (crisis or attacks)
• Low blood pressure (hypotension)
• Upper respiratory tract infection
• Difficulty breathing (dyspnea)
• Cough
• Indigestion (dyspepsia)
• Diarrhea
• Abdominal pain, upper abdominal pain
• Constipation
• Muscle spasms
• Back pain
• Low levels of calcium in the blood (hypocalcemia).

Not known: its frequency cannot be estimated from the 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 that may be associated with low calcium levels in the blood (QT prolongation 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. 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.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Cinacalcet Tillomed Composition

• The active ingredient is cinacalcet. Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride).
• The other components are:

• Tablet Core: Microcrystalline cellulose, low-substituted hydroxypropyl cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate.

• Tablet Coating:

HPMC 2910/Hypromellose (E464),

Lactose monohydrate,

Titanium dioxide (E171),

Triacetin,

FD&C Blue #2/Indigo Carmine AL 3%- 5%(E132),

Yellow Iron Oxide (E172).

Product Appearance and Packaging Contents

The 30 mg tablets are light green and oval-shaped, marked with “HP” on one side and “363” on the other.

Cinacalcet Tillomed is presented in a single-dose blister pack containing 28 or 84 tablets.

It is possible that not all packaging sizes will be marketed.

High-Density Polyethylene (HDPE) bottle with 30 tablets.

Marketing Authorization Holder

Laboratorios Tillomed Spain S.L.U.

C/ Cardenal Marcelo Spínola 8, 1st floor, door F

28016 Madrid

Spain

Responsible for Manufacturing1

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road, Portmarnock,

Co. Dublin, Ireland

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

SGS Pharma Magyarorszag Kft.

Derkovits Gyula Utca 53,

Budapest XIX, 1193,

Hungary

[1]Only the center that actually performs the release will be indicated in the marketed product.

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:September 2018

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