Cinacalcet Tillymed

Patient Information Leaflet

Cinacalcet Tillomed 30 mg, 60 mg and 90 mg film-coated tablets

Generic medicine
Please 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Cinacalcet is and what it is used for

Cinacalcet works by regulating levels of parathyroid hormone (PTH), calcium,
and phosphorus in the body. It is used to treat disorders caused by
problems with organs called parathyroid glands. The parathyroid glands are four
small glands located in the neck, near the thyroid gland, and they
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 elevated levels of calcium in the blood (hypercalcemia) in adult patients with parathyroid carcinoma.
• to reduce elevated levels of calcium in the blood (hypercalcemia) in adult patients with primary hyperparathyroidism when removal of the parathyroid gland is not possible.

Cinacalcet Tillomed must not be used in children aged between 3 and 18 years.
In both primary and secondary hyperparathyroidism, excessive amounts of PTH are produced by the parathyroid glands. "Primary" means that the hyperparathyroidism is not caused by other conditions, while "secondary" means that the hyperparathyroidism is caused by another condition, such as kidney disease. Both

primary and secondary hyperparathyroidism can cause loss of calcium from bone, which may lead to bone pain and fractures, blood and heart vessel problems, kidney stones, mental disturbances, and coma.

2. What you need to know before taking Cinacalcet

Do not take Cinacalcet

• if you are allergic (hypersensitive) to cinacalcet or to 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 blood calcium levels.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cinacalcet. Before taking Cinacalcet, inform your doctor if you have or have ever had:

• seizures (fits or convulsions). The risk of having seizures is higher if you have previously experienced convulsions;
• liver problems;
• heart failure. Cinacalcet lowers calcium levels. In adults treated with cinacalcet, life-threatening and fatal events associated with low calcium levels (hypocalcemia) have been reported. Inform your doctor if, during treatment with Cinacalcet, you experience any of the following symptoms, which may be signs of low calcium levels: muscle spasms, twitching or cramps, numbness or tingling in the fingers, toes or around the mouth, or seizures, confusion or loss of consciousness. Low calcium levels may affect heart rhythm. Inform your doctor if, while taking Cinacalcet, you notice an unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you are taking medicines known to cause heart rhythm disturbances. For further information, see section 4. During treatment with Cinacalcet, inform your doctor:
• if you have started or stopped smoking, as this may affect the action of Cinacalcet.

Children and adolescents
Cinacalcet Tillomed must not be administered to children under 18 years of age with parathyroid carcinoma or primary hyperparathyroidism.

Other medicines and Cinacalcet
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines, especially etelcalcetide or any other medicine that lowers calcium levels in the blood.
You must not take cinacalcet together with etelcalcetide.
Inform your doctor if you are taking the following medicines.
Medicines that may affect the action of Cinacalcet:

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

Cinacalcet may affect the action of the following medicines:

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

Cinacalcet with food and drink
Cinacalcet should be taken during or immediately after meals.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Cinacalcet has not been studied in pregnant women. During pregnancy, your doctor may decide to change your treatment, as Cinacalcet could harm the unborn baby.
It is not known whether Cinacalcet is excreted in breast milk. Your doctor will discuss with you whether you need to stop breastfeeding or stop treatment with Cinacalcet.

Driving and using machines
Dizziness and seizures have been reported in patients treated with cinacalcet. If you experience these side effects, do not drive or operate machinery.

Cinacalcet contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Cinacalcet

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will tell you how much Cinacalcet to take.
Cinacalcet should be taken orally, during or immediately after meals. The tablets must be swallowed whole and must not be chewed, crushed, or split.
Your doctor will perform regular blood tests during treatment to monitor your response to therapy and will adjust the dose if necessary.

If you are being treated for secondary hyperparathyroidism
The usual starting dose of Cinacalcet in adults is 30 mg (one tablet) once daily.

If you are being treated for parathyroid carcinoma 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
If you take more Cinacalcet than prescribed, contact your doctor immediately. 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 the missed dose.
If you have missed a dose of Cinacalcet, take your next scheduled dose at the usual time.

If you have any questions about 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 everyone experiences them.
Contact your doctor immediately if:

• You start to feel numbness or tingling around the mouth, muscle pain, cramps, or seizures. These symptoms may indicate that calcium levels are too low (hypocalcemia).
• You develop swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).

Very common: may occur in more than 1 out of 10 people

• Nausea and vomiting; these side effects are usually mild and short-lived.

Common: may occur in up to 1 out of 10 people

• Dizziness
• Numbness or tingling sensation (paresthesia)
• Loss (anorexia) or reduced appetite
• Muscle pain (myalgia)
• Weakness (asthenia)
• Skin rash
• Reduced testosterone levels
• Increased potassium levels in the blood (hyperkalemia)
• Allergic reactions (hypersensitivity)
• Headache
• Seizures (convulsions or fits)
• 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 calcium levels in the blood (hypocalcemia).

Not known: frequency cannot be estimated from available data

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

After administration of cinacalcet, a very small number of patients with
heart failure have experienced worsening of their condition and/or
low blood pressure (hypotension).
Reporting of side effects
If you experience any side effects, including those not listed in
this leaflet, consult your doctor or pharmacist. You may also report side
effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa . By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Cinacalcet

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
on the blister after "EXP.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Package contents and other information

What Cinacalcet contains

• The active substance is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
• The excipients are:
  o Tablet core: microcrystalline cellulose, low-substituted hydroxypropylcellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate
  o Tablet coating: HPMC 2910/hypromellose (E464)
  Lactose monohydrate
  Titanium dioxide (E171)
  Glycerol triacetate
  FD&C Blue No. 2 / indigotine 3-5% (E132)
  Yellow iron oxide (E172)

Description of the appearance of Cinacalcet and pack contents
The 30 mg tablets are light green, oval, biconvex, film-coated tablets, marked “HP” on one side and “363” on the other.
The 60 mg tablets are light green, oval, biconvex, film-coated tablets, marked “HP” on one side and “364” on the other.
The 90 mg tablets are light green, oval, biconvex, film-coated tablets, marked “HP” on one side and “365” on the other.
Cinacalcet Tillomed is available in single-dose blisters containing 28 and 84 tablets.
Not all pack sizes may be marketed.
High-density polyethylene (HDPE) bottle containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Tillomed Italia S.r.l.
Viale G. Richard 1, Torre A
20143, Milan
Italy

Manufacturers
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

This medicinal product is authorized in the European Economic Area member states under the following names:
Germany: Cinacalcet Tillomed 30 mg, 60 mg, 90 mg filmtabletten
Spain: Cinacalcet Tillomed 30 mg, 60 mg, 90 mg comprimidos recubiertos con película EFG
Italy: Cinacalcet Tillomed

This leaflet was last updated on 09/2023