Puncto Sleeptight Tablets
Package Leaflet: Information for The User
Puncto® SleepTight Tablets
Valerian root extract 75 mg Lemon balm leaf extract 45 mg Hops strobile extract 23 mg
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, you still need to take Puncto® SleepTight carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must consult a doctor or a qualified healthcare practitioner if your symptoms worsen or do not improve after 4 weeks.
• If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Puncto® SleepTight is and what it is used for
2. Before you take Puncto® SleepTight
3. How to take Puncto® SleepTight
4. Possible side effects
5. How to store Puncto® SleepTight
6. Further information
1. What Puncto® SleepTight is and
what it is used for
Puncto® SleepTight is a traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety, based on traditional use only.
2. Before you take Puncto® SleepTight
2.1 Do not take Puncto® SleepTight
• if you are allergic (hypersensitive) to any of the ingredients in your medicine (see section 6: Further information),
• if you are under 18 years old.
2.2 Take special care with Puncto® SleepTight
If your symptoms worsen or do not improve after 4 weeks, consult your doctor or qualified healthcare practitioner.
This product contains glucose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, you should consult your doctor before taking this product.
2.3 Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.
Do not take this medicine if you are already taking other medicines for sleep or anxiety.
2.4 Pregnancy and breast-feeding
Do not take this product if you are pregnant or breast feeding because there is no evidence that it is safe to do so.
2.5 Driving and using machines
This product may cause drowsiness. If you feel drowsy, do not drive or operate machines.
2.6 Taking this medicine and alcohol
The effects of this product may be increased by alcohol. Therefore, you should not drink excessive amounts of alcohol.
3. How to take Puncto® SleepTight
Always use Puncto® SleepTight exactly as instructed. You should check with your doctor or pharmacist if you are not sure.
3.1 How much Puncto® SleepTight to take
Remember to always take this medicine with a glass of water. The tablets should be swallowed whole and not chewed.
3.2 Adults and the elderly:
Take 2 tablets 1/2 to 1 hour before going to sleep.
You may need to take the tablets for 2 to 4 weeks continuously to get the best effect
Please turn over!
from the treatment. If your symptoms worsen or do not improve after 4 weeks, consult your doctor or a qualified healthcare practitioner.
Children and adolescents under 18 years of age:
This medicine is not recommended for children and adolescents under 18 years of age.
3.3 If you take more Puncto® SleepTight
than you should
If you take more than the recommended dose, speak to a doctor, pharmacist or a qualified healthcare practitioner and take this leaflet with you.
3.4 If you forget to take Puncto® SleepTight
Never take a double dose to make up for a missed dose. Take the next dose at the usual time. If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Puncto® SleepTight can cause side effects, although not everybody gets them.
Gastrointestinal symptoms such as nausea and abdominal cramps may occur after ingestion of Valerian root preparations. The frequency is not known. There are no known side effects with Hops or Lemon Balm.
If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. How to store Puncto® SleepTight
Keep out of the reach and the sight of children.
Do not use the tablets after the expiry date on the carton and the blister strip. The expiry date is the last day of that month.
Do not store above 30°C.
Store in the original package.
Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.
6. Further Information
What Puncto® SleepTight contains
The active ingredients in each coated tablet are: 75 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5-6:1), Extraction solvent: ethanol 70 % (v/v), 45 mg of extract (as dry extract) from Lemon balm leaf (Melissa officinalis L.) (46:1), Extraction solvent: water, and 23 mg of extract (as dry extract) Hop strobile (Humulus lupulus L.) (4-8:1), Extraction solvent: methanol 40 % (v/v).
Each tablet also contains 3.09 mg of glucose and 121.56 mg of sucrose.
The other ingredients are: Extract excipients: maltodextrin, colloidal anhydrous silica. Tablet core: microcrystalline cellulose, Copovidone (64), Povidone (90), stearic acid 50, talc. Tablet coating: carmellose sodium, Capol 600 (consisting of Carnauba wax, Cera alba, Shellac), spray-dried glucose liquid, Indigotine lacquer E 132, maize starch, Povidone (25), sucrose, colloidal anhydrous silica, talc, Titanium dioxide E171, Polysorbate 80.
What Puncto® SleepTight looks like and contents of the pack
Puncto® SleepTight is a light blue, biconvex and glossy coated tablet.
Puncto® SleepTight comes in blister packs of 60 or 100 coated tablets.
Traditional Herbal Registration Holder and Manufacturer
Traditional Herbal Registration Holder:
Grunwalder Gesundheitsprodukte GmbH, Ruhlandstr. 5, 83646 Bad Tolz, Germany
Manufacturer: Grunwalder Gesundheitsprodukte GmbH, Ruhlandstr. 5, 83646 Bad Tolz, Germany.
THR 18457/0020 certification mark
You can help to make medicines safer by reporting any side effects to the YellowCard Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper YellowCard form from your GP's surgery or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday-Friday).
For a large print, Braille or audio version of this leaflet, please contact: PlantaPhile Ltd., 18 Hyde Gardens, Eastbourne, East Sussex, BN21 4PT, UK.
This leaflet was last revised in February 2016.
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