CINACALCET APOTEX 60 MG FILM-COATED TABLETS
Active substance(s): CINACALCET HYDROCHLORIDE / CINACALCET HYDROCHLORIDE
Cinacalcet 30 mg, film-coated tablets
Cinacalcet 60 mg, film-coated tablets
Cinacalcet 90 mg, film-coated tablets
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.
What is in this leaflet:
1. What Cinacalcet tablets is and what it is used for
2. What you need to know before you take Cinacalcet tablets
3. How to take Cinacalcet tablets
4. Possible side effects
5. How to store Cinacalcet tablets
6. Contents of the pack and other information
1. What Cinacalcet Tablets is and what it is used for
Cinacalcet tablets works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous
in your body. It is used to treat problems with organs called parathyroid glands. The parathyroids are four
small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).
Cinacalcet tablets is used:
• to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear
their blood of waste products.
• to reduce high levels of calcium in the blood (hypercalcaemia) in patients with parathyroid cancer.
• to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary
hyperparathyroidism when removal of the gland is not possible.
In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroid glands.
“Primary” means that the hyperparathyroidism is not caused by any other condition and “secondary” means
that the hyperparathyroidism is caused by another condition, e.g., kidney disease. Both primary and
secondary hyperparathyroidism can cause the loss of calcium in the bones, which can lead to bone pain and
fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.
What you need to know before you take Cinacalcet Tablets
Do not take Cinacalcet tablets
- if you are allergic to Cinacalcet or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Cinacalcet tablets
Before you start taking Cinacalcet tablets, tell your doctor if you have or have ever had:
seizures (fits or convulsions). The risk of having seizures is higher if you have had them before;
Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been
reported in patients treated with Cinacalcet tablets.
Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an unusually
fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart
rhythm problems, while taking Cinacalcet tablets.
For additional information see section 4.
During treatment with Cinacalcet tablets, tell your doctor:
if you start or stop smoking, as this may affect the way Cinacalcet tablets works.
Children and adolescents
Children under the age of 18 must not take Cinacalcet tablets.
Other medicines and Cinacalcet tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking the following medicines.
Medicines such as these can affect how Cinacalcet tablets works:
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 HIV infection and AIDS (ritonavir);
a medicine used to treat depression (fluvoxamine)
Cinacalcet tablets may affect how medicines such as the following work:
• medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine);
• a medicine used to relieve cough (dextromethorphan);
• medicines used to treat changes in heart rate (flecainide and propafenone);
• a medicine used to treat high blood pressure (metoprolol).
Cinacalcet Tablets with food and drink
Cinacalcet tablets should be taken with or shortly after food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Cinacalcet tablets has not been tested in pregnant women. In case of pregnancy, your doctor may decide to
modify your treatment, as Cinacalcet tablets might harm the unborn baby.
It is not known whether Cinacalcet tablets is excreted in human milk. Your doctor will discuss with you if
you should discontinue either breast-feeding or treatment with Cinacalcet tablets.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Dizziness and
seizures have been reported by patients taking Cinacalcet tablets. If you experience these, your ability to
drive or operate machinery may be affected.
How to take Cinacalcet Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are unsure. Your doctor will tell you how much Cinacalcet tablets you must take.
Cinacalcet tablets must be taken orally, with or shortly after food. The tablets must be taken whole and are
not to be divided.
Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your
dose if necessary.
If you are being treated for secondary hyperparathyroidism
The usual starting dose for Cinacalcet tablets is 30 mg (one tablet) once per day.
If you are being treated for parathyroid cancer or primary hyperparathyroidism
The usual starting dose for Cinacalcet tablets is 30 mg (one tablet) twice per day.
If you take more Cinacalcet Tablets than you should
If you take more Cinacalcet tablets than you should you must contact your doctor immediately. Possible
signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.
If you forget to take Cinacalcet Tablets
Do not take a double dose to make up for a forgotten dose.
If you have forgotten a dose of Cinacalcet tablets, you should take your next dose as normal.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures you should
tell you doctor immediately. These may be signs that your calcium levels are too low (hypocalcaemia).
Very common: may affect more than 1 in 10 people
• nausea and vomiting, these side effects are normally quite mild and do not last for long.
Common: may affect up to 1 in 10 people
• numbness or tingling sensation (paraesthesia)
• loss (anorexia) or decrease of appetite
• muscle pain (myalgia)
• weakness (asthenia)
• reduced testosterone levels
• high potassium levels in the blood (hyperkalaemia)
• allergic reactions (hypersensitivity)
seizures (convulsions or fits)
low blood pressure (hypotension)
upper respiratory infection
breathing difficulties (dyspnoea)
abdominal pain, abdominal pain – upper
low calcium levels in the blood (hypocalcaemia).
Not known: frequency cannot be estimated from available data
• Hives (urticaria)
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
• Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood
(QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).
After taking Cinacalcet tablets a very small number of patients with heart failure had worsening of their
condition and/or low blood pressure (hypotension).
Children and adolescents
The use of Cinacalcet tablets in children and adolescents has not been established. A fatal outcome was
reported in an adolescent clinical trial patient with very low calcium levels in the blood (hypocalcaemia).
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
How to store Cinacalcet Tablets
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 that month
This medicinal product does not require any special temperature storage conditions. Store in the original
package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Cinacalcet Tablets contains
The active substance is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg and 90 mg of cinacalcet
The other ingredients are:
Sodium Starch Glycolate Type B
Silica, colloidal anhydrous
The tablets are coated with:
Titanium Dioxide (E 171)
Iron oxide yellow
Brilliant blue FCF (E 133), lake
Iron oxide black (E 172)
What Cinacalcet Tablets looks like and contents of the pack
Light green colored, oval shaped (9.525 x 5.95 mm), biconvex film-coated tablets, engraved “APO”
on one side and “C30” on the other side
Light green colored, oval shaped (11.90 x 7.50 mm), biconvex film-coated tablets, engraved
“APO” on one side and “C60” on the other side
Light green colored, oval shaped (13.493 x 8.35 mm), biconvex film-coated tablets, engraved
“APO” on one side and “C90” on the other side
Cinacalcet Tablets are available in blister packs of 28 or 84 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Apotex Europe B.V.
2333 CR Leiden
Apotex Nederland BV
Archimedesweg 2, 2333 CN Leiden, The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:>
Cinacalcet Tablets 30 mg, 60 mg and 90 mg, filmtabletten
The Netherlands: Cinacalcet Tablets 30 mg, 60 mg and 90 mg, filmomhulde tabletten
United Kingdom: Cinacalcet Tablets 30 mg, 60 mg and 90 mg, film-coated tablets
This leaflet was last revised in 04/2017
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.