<<

Package Leaflet: Information Do's and Don'ts Using Information for the user Read all of this leaflet carefully 1. What Valerian 2. What you need to Pregnancy and breast-feeding 3. How to take Valerian before you start taking this Complex is and what it know before you take Do not take this product if you Complex product because it contains are pregnant or breast-feeding important information for you. is used for Valerian Complex as it may not be suitable for you. Always take this product exactly as described in this leaflet or as your Valerian Always take this product exactly Valerian Complex is a traditional Do not take Valerian Complex Driving and using machines as described in this leaflet or as medicinal product containing doctor, pharmacist or nurse has If you are allergic to any of the This product is intended to help your doctor, pharmacist or nurse the tinctures of fresh Valerian root told you. Check with your doctor, Complex ingredients of this product (listed you relax. If you feel drowsy do has told you. and fresh strobile. pharmacist or nurse if you are not Stress Relief in section 6). not drive or operate machinery. sure. Keep this leaflet. You may It is used for the relief of symptoms The effects of this product need to read it again. Warnings and precautions Recommended dose oral drops of: may be increased by . See your doctor if your Tinctures of fresh Valerian & Hops Ask your pharmacist if you Mild mental stress Excessive use of alcohol should Adults and older people: Take need more information or symptoms worsen or do not therefore be avoided. 10-20 drops in a little water or fruit This is exclusively based on long- advice. improve within 2 weeks. juice once or twice daily. standing use. This product contains alcohol If you get any side effects, Children and adolescents (see below for alcohol content). The effects of this product may not Valerian Complex is for use in talk to your doctor, pharmacist Overdose of this product may be felt immediately. You may need adults. Do not give this product to or nurse. This includes any children or adolescents under 18 result in alcohol intoxication. to take it for up to 2 weeks for best possible side effects not listed years of age as it is not known if results. For oral short-term use only. Valerian Complex contains in this leaflet. See section 4. it is suitable for them. Do not take more than 40 drops alcohol You must talk to a doctor if Other medicines and a day. you do not feel better or if This medicinal product contains you feel worse after 2 weeks. Valerian Complex 62 vol % (alcohol), i.e. If you take more Valerian Do not take this product if you up to 280 mg per 20 drop dose, Complex than you should are already taking another equivalent to 7 ml beer (half a E What is in this leaflet If you take too much and feel ill, OBIL medicine which can cause tablespoon) or 3 ml wine (less STR talk to your doctor. PS 1. What Valerian Complex is and drowsiness. than a teaspoon) per dose. O Overdose of this product may H what it is used for Do not take this product if you Harmful for those suffering from result in alcohol intoxication and 2. What you need to know before are taking a medicine which is alcoholism. should be treated accordingly. you take Valerian Complex affected by alcohol. To be taken into account in 3. How to take Valerian Complex If you are speaking to your pregnant or breast-feeding 4. Possible side effects doctor, pharmacist or nurse women, children and high-risk always remember to tell them groups such as patients with 5. How to store Valerian Complex about any medicines you are liver disease, or epilepsy. 6. Contents of the pack and other taking, including herbal remedies information such as Valerian Complex. 41512INXNL xxxxxxxx/20190925

???

Please turn over...

296x160/111114 pharma code ??? Valerian Complex PIL IE TR Jan 2020_NL.indd 1 25/09/2019 08:54 296x160/111114 Valerian ComplexPIL IE TRJan2020_NL.indd2 doctor, pharmacist ornurse. on theuseof this product askyour If you have any furtherquestions Complex If you forget to take Valerian t takeadoubledoseto t worry aboutamissed make upfor aforgotten dose. Do no usual. dose. Take thenext doseas Do no ??? Using pharma code ??? information to becalculated. been enoughreports to allow this effects occur asthere have not not known how often these side is not known. Thismeans itis The frequency of these sideeffects concerned. a doctor orpharmacist ifyou are these are troubling you. Talk to Stop takingthisproduct ifyou find Side effects everybody gets them. cause sideeffects, althoughnot products,Like all thisproduct can Possible sideeffects 4. Digestive symptoms tomach pains eeling sick S F Side effects Reporting of sideeffects ou canalsoreport sideeffects ou get any sideeffects, talk eporting sideeffects this medicine. information onthesafety of you canhelpprovide more By r E-mail: [email protected] Website: www.hpra.ie Fax: +35316762517 Tel: +35316764971 IRL -Dublin2 Earlsfort Terrace HPRA Pharmac directly via: Y leaflet. side effects not listed inthis nurse. Thisincludes any possible to your doctor, pharmacist or If y

ovigilance

Valerian root tincture 20 drops of oral liquidcontains: contains What Valerian Complex and o Contents of thepack 6. C How to store Valerian 5. Extraction Ethanol 58%V/V solvent: ( L.) (1:10–11) L.) omplex t throw away any t usethisproduct ifyou oduct does not require t usethisproduct after the eep thisproduct outof the the environment. These measures helpprotect will medicines you nolongeruse. pharmacist how to throw away household waste. your Ask medicines viawastewater or greenish-brown incolour. It shouldbeaclear liquidthat is notice achangeinappearance. any specialstorage conditions. month. date refers to thelast day of that the labelandcarton. Theexpiry expiry date whichisstated on sight andreach of children. Do no Do no This pr Use within5monthso Do no K ther information Information

f opening. 263

mg liquid are ethanol andwater. The other ingredients usedfor the equivalent to 35drops. 1 mlof Valerian Complex is Extraction Ethanol65%V/V solvent: ( Hops strobile tincture 01/2020. This leaflet was last revised in TR 2309/020/001 Netherlands 8081 HCElburg, J.P. Broekhovenstraat 16, B.V.A.Vogel Manufacturer [email protected] Tel: 1890930070 Dublin 9, Ireland 48 UpperDrumcondra Road, Ireland Ltd,A.Vogel Registration Holder Traditional Herbal may bemarketed. and 50mlbottles. pack sizes Not all Complex isavailable in15ml,30ml is greenish-brown incolour. Valerian Valerian Complex is a clear liquid that the pack looks like andcontents of What Valerian Complex L.) (1:12–13) Humulus lupulusL.)

263

mg 1 890930070 this number: Call of thisleaflet. print oraudioversion You can get alarger Phone: 1890930070 E-mail: [email protected] you withfurtherinformation. phone andemailwhichcanprovide Ireland runsahelplinebyA.Vogel You shouldalsoknow Complex. Hops) isusedto makeValerian female flowers (commonly called female flowers. Theextract of the produces eithermaleor to theNorthernHemisphere. Each Hops are flowering plantsnative What are Hops? Valerian Complex. roots whichisusedto make ItistheextractAsia. of Valerian is native to andpartsof Valerian isaflowering plantwhich What isValerian?

25/09/2019 08:54

41512INXNL xxxxxxxx/20190925 Information Do's and Don'ts Using Package Leaflet: Read all of this leaflet carefully 1. What Valerian 2. What you need to Pregnancy and breast-feeding 3. How to take Valerian Information for the user before you start taking this Complex is and what it know before you take Do not take this product if you Complex product because it contains are pregnant or breast-feeding important information for you. is used for Valerian Complex as it may not be suitable for you. Always take this product exactly as described in this leaflet or as your Always take this product exactly Valerian Complex is a traditional Do not take Valerian Complex Driving and using machines as described in this leaflet or as herbal medicinal product containing doctor, pharmacist or nurse has If you are allergic to any of the This product is intended to help Valerian your doctor, pharmacist or nurse the tinctures of fresh Valerian root told you. Check with your doctor, ingredients of this product (listed you relax. If you feel drowsy do has told you. and fresh Hops strobile. pharmacist or nurse if you are not Complex in section 6). not drive or operate machinery. sure. Keep this leaflet. You may It is used for the relief of symptoms The effects of this product need to read it again. Warnings and precautions Recommended dose Stress Relief of: may be increased by alcohol. See your doctor if your oral drops Ask your pharmacist if you Mild mental stress Excessive use of alcohol should Adults and older people: Take need more information or symptoms worsen or do not therefore be avoided. 10-20 drops in a little water or fruit Tinctures of fresh Valerian & Hops This is exclusively based on long- advice. improve within 2 weeks. juice once or twice daily. standing use. This product contains alcohol If you get any side effects, Children and adolescents (see below for alcohol content). The effects of this product may not Valerian Complex is for use in talk to your doctor, pharmacist Overdose of this product may be felt immediately. You may need adults. Do not give this product to or nurse. This includes any children or adolescents under 18 result in alcohol intoxication. to take it for up to 2 weeks for best possible side effects not listed years of age as it is not known if results. For oral short-term use only. Valerian Complex contains in this leaflet. See section 4. it is suitable for them. Do not take more than 40 drops alcohol You must talk to a doctor if Other medicines and a day. you do not feel better or if This medicinal product contains you feel worse after 2 weeks. Valerian Complex 62 vol % ethanol (alcohol), i.e. If you take more Valerian Do not take this product if you up to 280 mg per 20 drop dose, Complex than you should What is in this leaflet are already taking another equivalent to 7 ml beer (half a If you take too much and feel ill, medicine which can cause tablespoon) or 3 ml wine (less talk to your doctor. BILE 1. What Valerian Complex is and drowsiness. than a teaspoon) per dose. TRO Overdose of this product may S what it is used for Harmful for those suffering from PS Do not take this product if you result in alcohol intoxication and O H 2. What you need to know before are taking a medicine which is alcoholism. should be treated accordingly. you take Valerian Complex affected by alcohol. To be taken into account in 3. How to take Valerian Complex If you are speaking to your pregnant or breast-feeding 4. Possible side effects doctor, pharmacist or nurse women, children and high-risk always remember to tell them groups such as patients with 5. How to store Valerian Complex about any medicines you are liver disease, or epilepsy. 6. Contents of the pack and other taking, including herbal remedies information such as Valerian Complex. 41512IN4aUK

Please turn over...

296x160/111114 pharma code ??? Valerian Complex PIL IE TR Jan ???2020.indd 1 25/09/2019 08:50 296x160/111114 Valerian ComplexPIL IE TRJan2020.indd2 doctor, pharmacist ornurse. on theuseof this product askyour If you have any furtherquestions Complex If you forget to take Valerian t takeadoubledoseto t worry aboutamissed make upfor aforgotten dose. Do no usual. dose. Take thenext doseas Do no ??? Using pharma code ??? information to becalculated. been enoughreports to allow this effects occur asthere have not not known how often these side is not known. Thismeans itis The frequency of these sideeffects concerned. a doctor orpharmacist ifyou are these are troubling you. Talk to Stop takingthisproduct ifyou find Side effects everybody gets them. cause sideeffects, althoughnot products,Like all thisproduct can Possible sideeffects 4. Digestive symptoms tomach pains eeling sick S F Side effects Reporting of sideeffects ou canalsoreport sideeffects ou get any sideeffects, talk eporting sideeffects this medicine. information onthesafety of you canhelpprovide more By r E-mail: [email protected] Website: www.hpra.ie Fax: +35316762517 Tel: +35316764971 IRL -Dublin2 Earlsfort Terrace HPRA Pharmac directly via: Y leaflet. side effects not listed inthis nurse. Thisincludes any possible to your doctor, pharmacist or If y

ovigilance

Valerian root tincture 20 drops of oral liquidcontains: contains What Valerian Complex and o Contents of thepack 6. C How to store Valerian 5. Extraction Ethanol 58%V/V solvent: ( L.) (1:10–11) Valeriana officinalis L.) omplex t throw away any t usethisproduct ifyou oduct does not require t usethisproduct after the eep thisproduct outof the the environment. These measures helpprotect will medicines you nolongeruse. pharmacist how to throw away household waste. your Ask medicines viawastewater or greenish-brown incolour. It shouldbeaclear liquidthat is notice achangeinappearance. any specialstorage conditions. month. date refers to thelast day of that the labelandcarton. Theexpiry expiry date whichisstated on sight andreach of children. Do no Do no This pr Use within5monthso Do no K ther information Information

f opening. 263

mg liquid are ethanol andwater. The other ingredients usedfor the equivalent to 35drops. 1 mlof Valerian Complex is Extraction Ethanol65%V/V solvent: ( Hops strobile tincture 01/2020. This leaflet was last revised in TR 2309/020/001 [email protected] Tel: +44(0)1294277344 Irvine, Ayrshire, KA115DD-UK 2 Brewster Place, Ltd,A.Vogel Manufacturer [email protected] Tel: 1890930070 Dublin 9, Ireland 48 UpperDrumcondra Road, Ireland Ltd,A.Vogel Registration Holder Traditional Herbal may bemarketed. and 50mlbottles. pack sizes Not all Complex isavailable in15ml,30ml is greenish-brown incolour. Valerian Valerian Complex is a clear liquid that the pack looks like andcontents of What Valerian Complex L.) (1:12–13) Humulus lupulusL.)

263

mg 1 890930070 this number: Call of thisleaflet. print oraudioversion You can get alarger Phone: 1890930070 E-mail: [email protected] you withfurtherinformation. phone andemailwhichcanprovide Ireland runsahelplinebyA.Vogel You shouldalsoknow Complex. Hops) isusedto makeValerian female flowers (commonly called female flowers. Theextract of the plant produces eithermaleor to theNorthernHemisphere. Each Hops are flowering plantsnative What are Hops? Valerian Complex. roots whichisusedto make ItistheextractAsia. of Valerian is native to Europe andpartsof Valerian isaflowering plantwhich What isValerian?

25/09/2019 08:50

41512IN4aUK