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SASTRAVI 50 MG/12.5 MG/200 MG FILM-COATED TABLETS

Active substance(s): CARBIDOPA / ENTACAPONE / LEVODOPA

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Package leaflet: Information for the user

Sastravi 50mg/12.5mg/200mg Film-coated Tablets
Sastravi 75mg/18.75mg /200mg Film-coated Tablets
Sastravi 100mg/25mg/200mg Film-coated Tablets
Sastravi 125mg/31.25mg/200mg Film-coated Tablets
Sastravi 150mg/37.5mg/200mg Film-coated Tablets
Sastravi 175mg/43.75mg/200mg Film-coated Tablets
Sastravi 200mg/50mg/200mg Film-coated Tablets
Levodopa/Carbidopa/Entacapone
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 or pharmacist.
• 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet

Your doctor may take some regular laboratory tests during a long term
treatment with Sastravi.
If you must undergo surgery, please tell your doctor that you are using
Sastravi.
Sastravi is not recommended to be used for treatment of
extrapyramidal symptoms (e.g. involuntary movements, shaking,
muscle rigidity and muscle contractions) caused by other medicines.
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before taking Sastravi.

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

Children and adolescents
Experience with Sastravi in patients under 18 years is limited.
Therefore, the use of Sastravi in children is not recommended.

1. What Sastravi is and what it is used for

Do not take Sastravi if you are taking certain medicines for treating
depression (combinations of selective MAO-A and MAO-B inhibitors, or
non-selective MAO inhibitors).

Sastravi contains three active substances (levodopa, carbidopa
and entacapone) in one film-coated tablet. Sastravi is used for the
treatment of Parkinson’s disease.
Parkinson’s disease is caused by low levels of a substance called
dopamine in the brain. Levodopa increases the amount of dopamine
and hence reduces the symptoms of Parkinson’s disease. Carbidopa
and entacapone improve the antiparkinson effects of levodopa.
2. What you need to know before you take Sastravi
Do not take Sastravi if you
• are allergic to levodopa, carbidopa or entacapone, soya, peanut or
any of the other ingredients of this medicine (listed in section 6)
• have narrow-angle glaucoma (an eye disorder)
• have a tumour of the adrenal gland
• are taking certain medicines for treating depression (combinations
of selective MAO-A and MAO-B inhibitors, or non-selective MAOinhibitors)
• have ever had neuroleptic malignant syndrome (NMS – this is a rare
reaction to medicines used to treat severe mental disorders)
• have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
• have a severe liver disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sastravi if you have or
have ever had:
• a heart attack or any other diseases of the heart including cardiac
arrythmias, or of the blood vessels
• asthma or any other disease of the lungs
• a liver problem, because your dose may need to be adjusted
• kidney or hormone-related diseases
• stomach ulcers or convulsions
• if you experience prolonged diarrhoea consult your doctor as it may
be a sign of inflammation of the colon
• any form of severe mental disorder like psychosis
• chronic wide-angle glaucoma, because your dose may need to be
adjusted and the pressure in your eyes may need to be monitored.
Consult your doctor if you are currently taking:
• antipsychotics (medicines used to treat psychosis)
• a medicine which may cause low blood pressure when rising from
a chair or bed. You should be aware that Sastravi may make these
reactions worse.
Consult your doctor if during the treatment with Sastravi you:
• notice that your muscles get very rigid or jerk violently, or if you get
tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations
in your blood pressure. If any of this happens, contact your doctor
immediately
• feel depressed, have suicidal thoughts, or notice unusual changes in
your behaviour
• find yourself suddenly falling asleep, or if you feel very drowsy. If this
happens, you should not drive or use any tools or machines (see also
section ‘Driving and using machines’)
• notice that uncontrolled movements begin or get worse after you
started to take Sastravi. If this happens, your doctor may need to
change the dose of your antiparkinson medicine
• experience diarrhoea: monitoring of your weight is recommended in
order to avoid potentially excessive weight loss
• experience progressive anorexia, asthenia (weakness, exhaustion)
and weight decrease within a relatively short period of time. If this
happens, a general medical evaluation including liver function
should be considered
• feel the need to stop using Sastravi, see section ‘If you stop taking
Sastravi’.
Tell your doctor if you or your family/carer notices you are developing
urges or cravings to behave in ways that are unusual for you or you
cannot resist the impulse, drive or temptation to carry out certain
activities that could harm yourself or others. These behaviours are
called impulse control disorders and can include addictive gambling,
excessive eating or spending, an abnormally high sex drive or a
preoccupation with an increase in sexual thoughts or feelings.
Your doctor may need to review your treatments.

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

Sastravi may increase the effects and side effects of certain medicines.
These include:
• medicines used to treat depression such as moclobemide,
amitryptiline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterole and isoprenaline, used to treat respiratory diseases
• adrenaline, used for severe allergic reactions
• noradrenaline, dopamine and dobutamine, used to treat heart
diseases and low blood pressure
• alpha-methyldopa, used to treat high blood pressure
• apomorphine, which is used to treat Parkinson’s disease.
The effects of Sastravi may be weakened by certain medicines. These
include:
• dopamine antagonists used to treat mental disorders, nausea and
vomiting
• phenytoin, used to prevent convulsions
• papaverine used to relax the muscles.
Sastravi may make it harder for you to digest iron. Therefore, do not
take Sastravi and iron supplements at the same time. After taking one
of them, wait at least 2 to 3 hours before taking the other.
Sastravi with food and drink
Sastravi may be taken with or without food. For some patients, Sastravi
may not be well absorbed if it is taken with, or shortly after eating
protein-rich food (such as meats, fish, dairy products, seeds and nuts).
Consult your doctor if you think this applies to you.
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.
You should not breast-feed during treatment with Sastravi.
Driving and using machines
Sastravi may lower your blood pressure, which may make you feel
light-headed or dizzy. Therefore, be particularly careful when you drive
or when you use any tools or machines.
If you feel very drowsy, or if you sometimes find yourself suddenly
falling asleep, wait until you feel fully awake again before driving or
doing anything else that requires you to be alert. Otherwise, you may
put yourself and others at risk of serious injury or death.
Sastravi contains lecithin (soya)
If you are allergic to peanut or soya, do not use this medicinal product.
3. How to take Sastravi
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
For adults and elderly:
• Your doctor will tell you exactly how many tablets of Sastravi to take
each day.
• The tablets are not intended to be split or broken into smaller pieces.
• You should take only one tablet each time.
• Depending on how you respond to treatment, your doctor may
suggest a higher or lower dose.
• If you are taking Sastravi 50mg/12.5mg/200mg,
75mg/18.75mg/200mg, 100mg/25mg/200mg,
125mg/31.25mg/200mg or 150mg/37.5mg/200mg tablets, do not
take more than 10 tablets per day.
• If you are taking Sastravi 175mg/43.75mg/200mg, do not take more
than 8 tablets per day.
• If you are taking Sastravi 200mg/50mg/200mg, do not take more
than 7 tablets per day.
Talk to your doctor or pharmacist if you think the effect of Sastravi is
too strong or too weak, or if you experience any side effects.
Use in children and adolscents
Sastravi should not be used in children and adolescents under 18 years
of age.

colours/plates:

Sastravi All Strengths PIL - UK/Eire

1. Black

item no: AAAG9198

dimensions: 190 x 380

print proof no: 3

pharmacode:

origination date: 02.06.14

min pt size: 8

MOCK UP
ONLY

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 06.08.14

Technical Approval

revised by: S.Anson

date sent: 02.06.14

supplier: Actavis Zdravlje Serbia

technically app. date: 03.06.14

Non Printing Colours
1.
2.
3.

If you take more Sastravi than you should
If you have accidentally taken more Sastravi tablets than you should,
talk to your doctor or pharmacist immediately. In case of an overdose
you may feel confused or agitated, your heart rate may be slower or
faster than normal or the colour of your skin, tongue, eyes or urine
may change.
If you forget to take Sastravi
Do not take a double dose to make up for a forgotten tablet.
If it is more than 1 hour until your next dose:
Take one tablet as soon as you remember, and the next tablet at the
normal time.
If it is less than 1 hour until your next dose:
Take a tablet as soon as you remember, wait 1 hour, then take another
tablet. After that carry on as normal.
Always leave at least an hour between Sastravi tablets, to avoid
possible side effects.
If you stop taking Sastravi
Do not stop taking Sastravi unless your doctor tells you to. In such
a case your doctor may need to adjust your other antiparkinson
medicines, especially levodopa, to give sufficient control of
your symptoms. If you suddenly stop taking Sastravi and other
antiparkinsonian medicines it may result in unwanted side effects.
If you have any further questions on 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. Many of the side effects can be relieved by
adjusting the dose.
If you during the treatment with Sastravi experience the following
symptoms, contact your doctor immediately:
• Your muscles get very rigid or jerk violently, you get tremors,
agitation, confusion, fever, rapid pulse, or wide fluctuations in your
blood pressure. These can be symptoms of neuroleptic malignant
syndrome (NMS, a rare severe reaction to medicines used to treat
disorders of the central nervous system) or rhabdomyolysis (a rare
severe muscle disorder).
• Allergic reaction, the signs may include hives (nettle rash), itching,
rash, swelling of your face, lips, tongue or throat. This may cause
difficulties in breathing or swallowing.
Very common: (may affect more than 1 in 10 people)
• uncontrolled movements (dyskinesias)
• feeling sick (nausea)
• harmless reddish-brown discoloration of urine
• muscle pain
• diarrhoea
Common: (may affect up to 1 in 10 people)
• light-headedness or fainting due to low blood pressure, high blood
pressure
• worsening of Parkinson’ s symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth,
constipation
• inability to sleep, hallucinations, confusion, abnormal dreams
(including nightmares), tiredness
• mental changes – including problems with memory, anxiety and
depression (possibly with thoughts of suicide)
• heart or artery disease events (e.g. chest pain), irregular heart rate or
rhythm
• more frequent falling
• shortness of breath
• increased sweating, rashes
• muscle cramps, swelling of legs
• blurred vision
• anaemia
• decreased appetite, decreased weight
• headache, joint pain
• urinary tract infection
Uncommon: (may affect up to 1 in 100 people)
• heart attack
• bleeding in the gut
• changes in the blood cell count which may result in bleeding,
abnormal liver function tests
• convulsions
• feeling agitated
• psychotic symptoms
• colitis (inflammation of the colon)
• discolourations other than urine (e.g. skin, nail, hair, sweat)
• swallowing difficulties
• inability to urinate
The following side effects have also been reported:
• hepatitis (inflammation of the liver)
• itching
You may experience the following side effects:
• Inability to resist the impulse to perform an action that could be
harmful, which may include:
• strong impulse to gamble excessively despite serious personal or
family consequences.
• altered or increased sexual interest and behaviour of significant
concern to you or to others, for example, an increased sexual drive.
• uncontrollable excessive shopping or spending
• binge eating (eating large amounts of food in a short time period) or
compulsive eating (eating more food than normal and more than is
needed to satisfy your hunger)
Tell your doctor if you experience any of these behaviours; they will
discuss ways of managing or reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via
United Kingdom
Yellow Card SchemeWebsite: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Sastravi
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
bottle and carton after ‘EXP.’ The expiry date refers to the last day of
that month.
This medicinal product does not require any special storage
conditions.
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.
6. Contents of the pack and other information
What Sastravi contains
• The active substances are levodopa, carbidopa and entacapone.
• Each film-coated tablet contains 50mg of levodopa, 12.5mg of
carbidopa (as monohydrate) and 200mg of entacapone.
• Each film-coated tablet contains 75mg of levodopa, 18.75mg of
carbidopa (as monohydrate) and 200mg of entacapone.
• Each film-coated tablet contains 100mg of levodopa, 25mg of
carbidopa (as monohydrate) and 200mg of entacapone.
• Each film-coated tablet contains 125mg of levodopa, 31.25mg of
carbidopa (as monohydrate) and 200mg of entacapone.
• Each film-coated tablet contains 150mg of levodopa, 37.5mg of
carbidopa (as monohydrate) and 200mg of entacapone.
• Each film-coated tablet contains 175mg of levodopa, 43.75mg of
carbidopa (as monohydrate) and 200mg of entacapone.
• Each film-coated tablet contains 200mg of levodopa, 50mg of
carbidopa (as monohydrate) and 200mg of entacapone.
• The other ingredients are Tablet core: croscarmellose sodium,
hydroxypropylcellulose, trehalose dihydrate, powdered cellulose,
anhydrous sodium sulfate, microcrystalline cellulose, magnesium
stearate.
• F ilm coat: polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide
(E171), macrogol, iron oxide red (E172), lecitin (soya) (E322), iron
oxide yellow (E172).
What Sastravi looks like and contents of the pack
Sastravi 50mg/12.5mg/200mg: Brownish red, oval, biconvex filmcoated tablet 6.85 x 14.2 mm with “50” marked on one side and “LEC”
on the opposite side.
Sastravi 75mg/18.75mg/200mg: Brownish red, oval, biconvex filmcoated tablet 7. 04 x 14.7 mm with “75” marked on one side and “LEC”
on the opposite side.
Sastravi 100mg/25mg/200mg: Brownish red, oval, biconvex filmcoated tablet 7.23 x 15.3 mm with “100” marked on one side and “LEC”
on the opposite side.
Sastravi 125mg/31.25mg/200mg: Brownish red, oval, biconvex filmcoated tablet 7.5 x 15.8 mm with “125” marked on one side and “LEC”
on the opposite side.
Sastravi 150mg/37.5mg/200mg: Brownish red, oval, biconvex filmcoated tablet 7.68 x 16.2 mm with “150” marked on one side and “LEC”
on the opposite side.
Sastravi 175mg/43.75mg/200mg: Brownish red, oval, biconvex filmcoated tablet 7.92 x 16.6 mm with “175” marked on one side and “LEC”
on the opposite side.
Sastravi 200mg/50mg/200mg: Brownish red, oval, biconvex filmcoated tablet 8.21 x 17.2 mm with “200” marked on one side and “LEC”
on the opposite side.
Tablet container with screw cap:
30 and 100 Film-coated Tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in August 2014

If you would like a
leaflet with larger
text, please contact
UK: 01271 385257
IE: 1890 333231

Actavis, Barnstaple, EX32 8NS, UK
Actavis Ireland, Euro Hs, Little Island, Cork

AAAG9198

colours/plates:

Sastravi All Strengths PIL - UK/Eire

1. Black

item no: AAAG9198

dimensions: 190 x 380

print proof no: 3

pharmacode:

origination date: 02.06.14

min pt size: 8

MOCK UP
ONLY

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 06.08.14

Technical Approval

revised by: S.Anson

date sent: 02.06.14

supplier: Actavis Zdravlje Serbia

technically app. date: 03.06.14

Non Printing Colours
1.
2.
3.

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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.

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