MOTAC 1000 mg Soft Capsule

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1. MOTAC 1000 mg soft capsules
   1. What is MOTAC and what is it used for
   2. What you need to know before taking MOTAC
   3. How to take MOTAC
   4. Possible side effects
   5. How to store MOTAC
   6. Contents of the pack and other information

MOTAC 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again. If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful. If you experience any side effects, including those not listed in this leaflet, please
• consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is MOTAC and what is it used for

MOTAC contains as active ingredients ethyl esters of polyunsaturated fatty acids (derived from fish oil)
at high concentration and purity, which reduce the level of certain fats in the blood (triglycerides) and
which have positive effects on the heart and blood vessels.
MOTAC is indicated:

• to reduce high levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with MOTAC must always be associated with adequate dietary rules.

2. What you need to know before taking MOTAC

Do not take MOTAC

• if you are allergic to ethyl esters of polyunsaturated fatty acids (derived from fish oil) or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking MOTAC.
Tell your doctor before taking MOTAC:

• if you are allergic to fish, as the active ingredient of MOTAC is derived from fish oil;
• if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are using high doses of MOTAC;
• if you have bleeding disorders.

Other medicines and MOTAC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are being treated with:

• medicines to thin the blood (anticoagulants) e.g. coumarin anticoagulants
• other medicines that affect blood clotting because an increase in bleeding time may occur.

Pregnancy and breastfeeding
Do not use MOTAC if you are pregnant or breastfeeding.

Driving and using machines
MOTAC does not impair the ability to drive vehicles or use machines.

3. How to take MOTAC

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Take the MOTAC capsules whole with a little water.

Use in adults
For the reduction of elevated levels of fats (triglycerides) in the blood.
The recommended dose is 1 capsule of 1000 mg 1-3 times a day, as prescribed by your doctor.

Use in the paediatric population
No data are available on the use of MOTAC in the paediatric population in the authorised indications.

Use in elderly patients and patients with impaired renal function
No dose adjustment is required in these patients.

Use in patients with impaired hepatic function
Your doctor will monitor your liver function during treatment, especially if you are using
high doses of MOTAC (see section “Warnings and precautions”).

If you take more MOTAC than you should
In case of accidental ingestion of an excessive dose of MOTAC, inform your doctor or pharmacist.

If you forget to take MOTAC
Do not take a double dose to make up for a missed dose.

If you stop taking MOTAC
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• stomach and/or intestinal disorders

Uncommon side effects (may affect up to 1 in 100 people)
nausea

• difficulty digesting
• pain in the upper part of the abdomen
• diarrhoea

Rare side effects (may affect up to 1 in 1,000 people)

• allergic reactions (hypersensitivity), allergy to the components
• dizziness
• inflammation of the stomach and/or intestines (gastritis, gastroenteritis)
• abdominal pain
• heartburn
• alteration of liver function
• skin reactions
• weakness

Other side effects that have occurred in a very small number of people, but whose
exact frequency is unknown

• itching
• itchy skin rash (urticaria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store MOTAC

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 packaging after Exp. The date
of expiry refers to the last day of that month.
Store at a temperature below 30 ° C. Store in the blister pack to protect from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MOTAC contains

• The active ingredients are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 1000 mg of ethyl esters of polyunsaturated fatty acids, with an EPA and DHA content of not less than 85% and a ratio between them of 0.9 - 1.5.
• The other components are alpha-tocopherol, gelatin succinate, glycerol, medium-chain triglycerides, purified water.

Description of the appearance of MOTAC and contents of the pack
Soft, transparent, oblong capsules containing a clear oil, of a light yellow color, with a
characteristic fishy odor.
Each pack contains 20 or 30 soft capsules in a white-opaque heat-sealed blister made of PVC/PVDC-
AL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Epifarma S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)

Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza)